510(k) K021589 ยท DQY Catheter, Percutaneous
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
| Applicant | Medtronic Vascular, Minneapolis MN, US |
| Decision | Substantially Equivalent, May 30, 2002 |
| Received | May 15, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2008 | Medtronic Inc. Cardiac Rhythm Managment Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Mi Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.