510(k) K172567 ยท MJN Catheter, Intravascular Occluding, Temporary
GORE Molding and Occlusion Balloon Catheter
| Applicant | W. L. Gore and Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Jan 31, 2018 |
| Received | Aug 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172567
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2021 | W. L. Gore & Associates Inc. Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489 Open, Classified |
MJN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.