Angiographic catheters
Nylex
A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.
Nylex models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 526410 | Length 65 cm | Not stated | Available |
| 526411 | Catheter Gauge 4 Fr; Length 90 cm | Not stated | Available |
| 526412 | Length 100 cm | Not stated | Available |
| 526420 | Length 65 cm | Not stated | Available |
| 526421 | Length 90 cm | Not stated | Available |
| 526422 | Length 100 cm | Not stated | Available |
| 526430 | Length 65 cm | Not stated | Available |
| 526431 | Length 90 cm | Not stated | Available |
| 526440 | Length 65 cm | Not stated | Available |
| 526442 | Length 100 cm | Not stated | Available |
| 526510 | Length 65 cm | Not stated | Available |
| 526511 | Length 90 cm | Not stated | Available |
| 526512 | Length 100 cm | Not stated | Available |
| 526520 | Length 65 cm | Not stated | Available |
| 526521 | Length 90 cm | Not stated | Available |
| 526522 | Length 100 cm | Not stated | Available |
| 526523 | Length 110 cm | Not stated | Available |
| 526530 | Length 65 cm | Not stated | Available |
| 526540 | Length 65 cm | Not stated | Available |
| SRD7034 | Length 65 cm | Not stated | Available |
FDA clearances
- 510(k) K181836 August 2018
Procedures that use angiographic catheters
Frequently asked questions
What is Nylex used for?
A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.
Who makes Nylex?
Nylex is made by Cordis US Corp.. It is listed under angiographic catheters in our device library.
What sizes does Nylex come in?
Sizes listed for Nylex: Length: 65–110 cm; Catheter Gauge: 4 Fr. Confirm availability with the manufacturer's instructions for use.
Is Nylex MRI safe?
The FDA device database entry for Nylex does not state its MRI safety status. Check the labeling before MRI.
Is Nylex FDA cleared?
Nylex is covered by FDA submission K181836.
How do I contact a Cordis US Corp. sales representative?
Cordis US Corp. has not listed representatives on LA Vascular yet. Visit the Cordis US Corp. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.