510(k) K132022 ยท MJN Catheter, Intravascular Occluding, Temporary
LEMAITRE 8F OCCLUSION CATHETER
| Applicant | LeMaitre Vascular, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Nov 6, 2013 |
| Received | Jul 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132022
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2019 | LeMaitre Vascular, Inc. The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon Terminated |
MJN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.