🏭 Manufactured in our ISO 13485-certified facility in Guangdong, China. Every catheter pressure-tested at 1.5× rated working pressure before EO sterilization.
EKINSUN manufactures single-use angiography contrast catheters for interventional cardiologists, vascular surgeons, and radiologists worldwide. Our braided PTFE/Pebax shaft delivers the torque response and kink resistance required for navigating complex vascular anatomy under fluoroscopy, while the Luer-lock hub ensures leak-free connection to power injectors at up to 1200 psi.
| French sizes | 4Fr · 5Fr · 6Fr · 7Fr · 8Fr |
| Working lengths | 65cm / 80cm / 100cm / 110cm |
| Tip shapes (stock) | Pigtail · Judkins R/L · Cobra C1/C2 · Straight |
| Tip shapes (custom) | Amplatz · Multipurpose · Any OEM shape |
| Shaft construction | PTFE inner liner / Nylon braid / Pebax outer |
| Max rated pressure | 1200 psi (82.7 bar) |
| Guidewire compatibility | 0.035" / 0.038" standard · 0.018" / 0.025" custom |
| Hub connector | ISO 594 Luer-lock · color-coded by Fr size |
| Coating option | Hydrophilic — tested per ISO 10993-12 |
| Sterilization | EO sterile · SAL 10⁻⁶ · single-use |
| Shelf life | 5 years from sterilization date |
| Packaging | Individual sterile peel-pack (double-pouch option) |
| Certification | CE · ISO 13485 · ISO 10555 |
| Stock lead time | 7–10 business days |
| Custom lead time | 30–45 days from approved drawing |
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Clinical Applications & Buyer Segments
Contrast catheters are used across three primary clinical settings, each with distinct procurement patterns and technical requirements:
1. Cardiovascular Angiography (Cardiac Cath Labs)
Judkins Right and Left catheters are the most commonly used shapes for coronary angiography — the JR4.0 for right coronary and JL3.5/JL4.0 for left coronary artery access from the femoral or radial approach. Pigtail catheters are used for left ventriculography and aortography. Procurement decision-makers in cardiac catheterization laboratories source these as high-volume consumables, typically through group purchasing organizations (GPOs) or regional medical distributors. Key concerns: consistent tip integrity, shaft torque response, and batch-to-batch dimensional consistency.
2. Peripheral Vascular & Interventional Radiology
Cobra and multipurpose catheters are used for selective vessel cannulation in peripheral angiography, visceral angiography, and endovascular procedures. Longer catheter lengths (100cm, 110cm) are preferred for femoral access. The hydrophilic coating option is particularly valued for navigating tortuous iliac vessels. Procurement in this segment is typically through hospital supply chains or interventional device distributors.
3. Urological Contrast Studies
Straight-tip catheters in smaller French sizes (4Fr–5Fr) are used for retrograde urethrography, cystography, and urological contrast studies. Also see our HSG catheter for gynecological contrast imaging.
For distributors: EKINSUN contracts are common among medical distributors supplying hospitals in Europe, the Middle East, Southeast Asia, and Latin America. We support regulatory documentation requirements for CE, ANVISA, SFDA, and other regional authorities.
Tip Shape Selection Guide
| Tip Shape | Primary Use | Access Route | Fr Size Typical |
|---|---|---|---|
| Pigtail | Left ventriculography, aortography | Femoral / Radial | 5Fr–6Fr |
| Judkins Right (JR3.5 / JR4.0) | Right coronary angiography | Femoral / Radial | 5Fr–6Fr |
| Judkins Left (JL3.5 / JL4.0) | Left coronary angiography | Femoral / Radial | 5Fr–6Fr |
| Amplatz Left / Right | Complex coronary anatomy, TAVI guidance | Femoral | 6Fr–7Fr |
| Cobra C1 / C2 | Selective visceral, renal, mesenteric | Femoral | 4Fr–5Fr |
| Straight | Urological, general access | Various | 4Fr–6Fr |
| Multipurpose | Right heart, bypass graft | Femoral / Brachial | 5Fr–6Fr |
Construction & Quality Highlights
Braided Shaft Technology
The three-layer shaft construction — PTFE inner liner, high-tensile nylon braid, Pebax outer jacket — provides three critical performance properties simultaneously: low friction for smooth guide wire exchange (PTFE liner), torque transmission for precise tip control under fluoroscopy (nylon braid), and kink resistance during navigation of curved vessel anatomy (Pebax outer). The braid density can be adjusted per OEM specification to achieve different shaft flexibility profiles along the catheter length.
Hydrophilic Coating
Our optional hydrophilic coating activates on contact with saline or blood, creating a slippery surface that significantly reduces insertion friction in tortuous or spastic vessels. The coating is bonded to the shaft surface using a validated process and tested for lubricity retention after simulated clinical use cycles, and for particulate generation per ISO 10993-12.
Hub Design & Pressure Testing
The medical-grade polycarbonate Luer-lock hub is ISO 594 compliant and color-coded by French size for fast identification in the cath lab. Every catheter undergoes 100% pressure testing at 1.5× rated working pressure (1800 psi) before EO sterilization. Batches failing pressure test are quarantined and investigated before any release.
OEM & Private Label Process
EKINSUN's standard OEM workflow for contrast catheters:
- NDA — signed before receiving any design files or proprietary specifications
- Technical review — dimensional drawing or sample catheter measurement via CMM
- Tooling quotation — typically 5–7 business days after receiving drawings
- First article production — 30–45 days; first article report (FAR) with full dimensional check supplied
- Client approval — physical sample and FAR sent for sign-off
- Production run — 15–25 days after approval; EO sterilization adds 7–10 days
- Documentation package — CE DoC, ISO 13485 cert, sterilization cert, CoA per batch
Related Products in the Contrast Imaging Line
HSG Catheter
Fallopian tube contrast imaging
HP Injector Set 150ml
CT/MRI power injection kit
HP Extension Tubes
T/Y type, 1200 psi rated
Luer Connectors
ISO 594, custom OEM
Contrast Stopcock
High-pressure, power injector rated
Frequently Asked Questions
Pigtail, Judkins Right (JR3.5, JR4.0), Judkins Left (JL3.5, JL4.0), Cobra C1/C2, and Straight tips are kept in stock across most Fr sizes. Amplatz Left/Right, Multipurpose, and fully custom tip geometries require 30–45 days tooling lead time from approved drawing or sample.
Yes. Send us a sample catheter or technical drawing with dimensional tolerances. We perform CMM measurement and produce a match-spec first article for client approval before committing to production tooling. NDA signed before receiving any proprietary design files.
Our standard braided shaft is rated to 1200 psi (82.7 bar) working pressure, tested at 1.5x rated pressure (1800 psi) per ISO 10555. This is compatible with all standard power injector platforms including Medrad Stellant, Nemoto A-60, and Ulrich Missouri at clinical flow rates up to 10 ml/s.
Yes. CE declaration of conformity, ISO 13485 certificate, and ISO 10555 test report are supplied with every shipment. Full technical file including design history, risk management report (ISO 14971), and clinical evaluation available under NDA for regulatory review.
Standard inner lumen accommodates 0.035 inch (0.89mm) and 0.038 inch (0.97mm) guidewires. Custom inner lumen for 0.018 inch or 0.025 inch guidewires available at 500 pcs MOQ with 30 day lead time.
500 pcs for custom peel-pack label with your logo and product information. 1000 pcs for full outer carton printing with your brand, barcode, and multilingual IFU insert. We can also supply unbranded stock for your own labeling operation.
Yes. Hydrophilic coating significantly reduces surface friction during catheter navigation in tortuous vessels. Available on request at the same MOQ. Coating is tested for lubricity retention and particulate generation per ISO 10993-12.
We supply free samples (buyer covers DHL/FedEx shipping cost) for qualified distributors, hospital procurement teams, and OEM device companies. WhatsApp or email us with your company details and the catheter specification you need.
Shelf life is 5 years from EO sterilization date when stored below 30°C, away from direct sunlight and humidity. Each peel-pack includes a sterilization date label and batch number for full traceability.
Yes. Single peel-pack per catheter is standard. Double-pouch sterile barrier, blister tray, and bulk non-sterile supply for customer sterilization are all available. Specify packaging requirement at inquiry stage.
Shaft: PTFE inner liner, high-tensile nylon braid, Pebax outer jacket. Hub: medical-grade polycarbonate. All materials comply with ISO 10993 biocompatibility testing including cytotoxicity, sensitization, and intracutaneous reactivity. Material certificates provided per batch.
Yes. Full OEM service including custom peel-pack artwork, outer carton, IFU design and print, and regulatory document support (CE technical file, 510k support data). We have worked with distributors in Europe, Middle East, Southeast Asia, and Latin America.