Trak Back II
by Jomed, Inc.
510(k) K003938
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003938 | Date18 Jan 2001 | StatusActive |
Recalls
-
- Terminated Z-2636-2014
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Trak Back II is an intravascular diagnostic catheter designed for use in cardiovascular procedures. It is classified under the product code DQO and falls under the broader category of catheters intended for intravascular diagnostic purposes. This device is intended for imaging and guiding within blood vessels, aiding in diagnostic and interventional procedures within the cardiovascular system.
The Trak Back II is supplied by Jomed, Inc. and is intended for single-use applications, as indicated by its regulatory submission. It is regulated under the FDA’s 510(k) pathway with clearance number K003938, granted under a special review process in the Cardiovascular advisory committee. The device is classified as Class II and is intended for use in controlled clinical settings, adhering to CFR Title 21 standards. No third-party review was involved in its clearance.