510(k) K925442 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
SARNS RETROGRADE CANNULA
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, May 21, 1993 |
| Received | Oct 28, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, steerable stylet, ribbed balloon; catalog number 5578. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, malleable stylet, ribbed balloon; catalog number 5579. Terminated |
DWF | None listed |
| Aug 17, 2004 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, guidewire stylet, ribbed balloon; catalog number 5580. Terminated |
DWF | None listed |
| Aug 29, 2003 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 5578 Terminated |
74D | None listed |
| Aug 29, 2003 | Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 5579 Terminated |
74D | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.