510(k) K990829 ยท MCW Catheter, Peripheral, Atherectomy
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, May 4, 1999 |
| Received | Mar 12, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K990829
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2009 | Arrow International Inc Arrow Percutaneous Thrombolytic Device (PTD) for fistula and dialysis grafts Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.