510(k) K003938 ยท DQO Catheter, Intravascular, Diagnostic
TRAK BACK II
| Applicant | Jomed, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Jan 18, 2001 |
| Received | Dec 20, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2014 | Volcano Corporation Volcano TrakBack II Disposable Pullback Device;
Sterile and nonpyrogenic; Single Use.
TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data. Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.