510(k) K101591 ยท DQY Catheter, Percutaneous
STINGRAY ORIENTING BALLOON CATHETER
| Applicant | Bridgepoint Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 6, 2010 |
| Received | Jun 7, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2012 | Bridgepoint Medical BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441.
St Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.