510(k) K923231 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
CARDIO-PAK BASIC PUMP PACK
| Applicant | Cardio-Med-Associates, Inc., Billings MT, US |
| Decision | Unknown, Jul 9, 1993 |
| Received | Jul 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2003 | Windstone Medical, Inc. Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, e Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.