510(k) K113845 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jan 25, 2012 |
| Received | Dec 28, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.