510(k) K800178 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
EXTRACORP.'S INTERSEPT CUS. TUBING PK.
| Applicant | Extracorporeal Medical Specialities, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Feb 21, 1980 |
| Received | Jan 28, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800178
| 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 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide Terminated |
DWE | None listed |
| Aug 27, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9.
Sterilized by Ethylene Oxide, Do no Reuse.
Product Usage:
This pr Terminated |
DWE | 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/ Kerkrade.
Contain Medtronic Venous Cannula, Sterile EO.
Model #'s
C330201C, C330201D, C330201E, C330206B, C342603A, C350106A, C390101D, C390203D, C390406C, C390409B, C390601C, C390601 Terminated |
DWE | None listed |
| Jun 23, 2009 | Medtronic Cardiovascular Revascularization & Surgical Therap Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits Terminated |
DWE | 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 |
| Jan 25, 2007 | Medtronic Perfusion Systems Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any c Terminated |
DWE | None listed |
| May 10, 2005 | Medtronic Perfusion Systems Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Terminated |
DWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.