K112917 is an FDA 510(k) clearance for the ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID. 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 October 27, 2011, 24 days after receiving the submission on October 3, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K112917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2011 |
| Decision Date | October 27, 2011 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |