K080428 is an FDA 510(k) clearance for the ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on December 9, 2008, 294 days after receiving the submission on February 19, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K080428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2008 |
| Decision Date | December 09, 2008 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |