XTRAK Support Catheter
by Xtrak Medical, Inc. 510(k)
Active
510(k) K032660
Overview
The XTRAK Support Catheter is a vascular access device classified under product code DQY, designed to assist in the navigation and support of steerable guidewires within the vasculature. It features a flexible distal section composed of closely-wound coils, a torqueable mid-section for directional control, and a proximal handle with integrated strain relief. This design enables precise catheter placement and stabilization during interventional procedures, particularly for venous stenting applications.
This device is supplied as a single-use medical instrument and is intended for use in clinical settings requiring vascular access and guidewire support. It is not intended for MRI use and must be handled and stored according to manufacturer guidelines to maintain sterility and functionality. The XTRAK Support Catheter was cleared through the FDA 510(k) pathway in 2003 under the Traditional clearance type, with a decision of Substantially Equivalent (SESE) by the Cardiovascular Advisory Committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032660 | Date29 Oct 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Xtrak Medical, Inc.
Questions
What is the primary purpose of the XTRAK Support Catheter in medical procedures?
The XTRAK Support Catheter is designed to assist in navigating and stabilizing steerable guidewires within blood vessels, particularly during venous stenting procedures. Its flexible distal coil section and torqueable mid-section allow for precise catheter placement and enhanced control, reducing the risk of guidewire misplacement or damage during interventions.
Is the XTRAK Support Catheter intended for reuse, or is it meant to be used only once?
The XTRAK Support Catheter is explicitly supplied as a single-use medical instrument. Reusing it could compromise sterility, functionality, or patient safety, so it must be discarded after one use and replaced with a new, sterile device for subsequent procedures.
How should the XTRAK Support Catheter be stored to ensure it remains functional and sterile?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and integrity. Since it is single-use, it should be kept in its original, sealed packaging until immediately before use. Avoid exposure to moisture, extreme temperatures, or physical stress, as these could damage the catheter’s structure or compromise its sterile condition.
Can the XTRAK Support Catheter be used in MRI environments, or is it MRI-safe?
The XTRAK Support Catheter is not intended for MRI use. Its materials or design may not be compatible with magnetic resonance imaging, and using it in an MRI environment could pose risks to both the patient and the imaging equipment. Always verify the procedure environment’s compatibility before use.
What regulatory pathway was followed for the FDA clearance of the XTRAK Support Catheter, and when was it cleared?
The XTRAK Support Catheter was cleared through the FDA’s 510(k) pathway in 2003 under the Traditional clearance type, with a decision of Substantially Equivalent (SESE) by the Cardiovascular Advisory Committee. This means it was deemed comparable to a legally marketed predicate device at the time of review.