K012130 is an FDA 510(k) clearance for the ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 28, 2001, 50 days after receiving the submission on July 9, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K012130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2001 |
| Decision Date | August 28, 2001 |
| Days to Decision | 50 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 |