510(k) K905224 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
CARDIOPULMONARY BYPASS VASCULAR CATHETER
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Feb 5, 1991 |
| Received | Nov 20, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905224
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating
Product Usage: The Venous Return Cannula is indicated for venous dra Terminated |
DWF | None listed |
| Jul 23, 2014 | Terumo Cardiovascular Systems Corporation CPB Catheter Kit
Product Usage:
Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.