510(k) K091527 ยท DQY Catheter, Percutaneous
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Jun 12, 2009 |
| Received | May 26, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091527
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2018 | Cook Inc. Advance 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524
Product Usage:
The Advance 35LP Low Pro Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.