510(k) K141118 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jul 18, 2014 |
| Received | Apr 30, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141118
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2025 | ev3 Inc Medtronic NanoCross Elite PTA catheter,
REF numbers amd sizes:
1) AB14W050020090, Size: 5MM X 20MM X 90CM;
2) AB14W050020150, Size: 5MM X 20MM X 150CM;
3) AB14W050040090, Size: 5MM X 40MM X Open, Classified |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.