510(k) K012538 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
| Applicant | Medtronic Vascular, Minneapolis MN, US |
| Decision | Substantially Equivalent, Aug 23, 2001 |
| Received | Aug 7, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012538
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2016 | Medtronic Perfusion Systems Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO.
Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Terminated |
DWF | None listed |
| Oct 28, 2015 | Medtronic Perfusion Systems Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide.
The Tubing Pack design and components are specified by the user, they are packaged with consi Terminated |
DWF | None listed |
| 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 |
| Aug 27, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7.
Sterilized by E Terminated |
DWF | None listed |
| Dec 28, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers:
Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.