510(k) K891687 ยท DTZ Oxygenator, Cardiopulmonary Bypass
EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
| Applicant | Medtronic Blood Systems, Inc., Anaheim CA, US |
| Decision | Substantially Equivalent, May 31, 1989 |
| Received | Mar 22, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891687
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2018 | Medtronic Perfusion Systems Extra corporeal circuit with bio-active surface. Terminated |
DTZ | None listed |
| 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 |
| 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 Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7.
Sterilized by Ethylene Oxide, Do no Reuse.
Product Usage: Usage:
This product is indica Terminated |
DTZ | 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 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Custom Packs/Mexico,
Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model #
DLP6N48R3 & DLP6N48R4.
Medtronic Intersept Custom Tubing Pack with Trillium Biosurface, Terminated |
DTZ | None listed |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB1Z69R12, CB1Z69R12, Terminated |
DTZ | None listed |
| Sep 25, 2007 | Medtronic Perfusion Systems Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA.
Different components and Terminated |
DWE | None listed |
| Mar 8, 2007 | Medtronic Perfusion Systems Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one of them is 132 inch in length and is capped. The second line is 102 inch in length and has a one way vacuu Terminated |
DWE | None listed |
| Sep 29, 2004 | Medtronic Inc Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.