510(k) K122811 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Oct 12, 2012 |
| Received | Sep 13, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122811
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2015 | Medtronic Perfusion Systems MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11,
TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3,
TL7M46R7, TL2Q68R Terminated |
DWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.