510(k) K103386 ยท DQY Catheter, Percutaneous
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
| Applicant | Medtronic, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Feb 11, 2011 |
| Received | Nov 18, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103386
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F
Product Usage: The Medtronic Guiding Catheter is designed to provide a pathw Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.