510(k) K965209 ยท DSP System, Balloon, Intra-Aortic And Control
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
| Applicant | Arrow Intl., Inc., Everett MA, US |
| Decision | Substantially Equivalent, Jan 23, 1998 |
| Received | Dec 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2008 | Arrow International Inc ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149 Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.