K021589 is an FDA 510(k) clearance for the ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218. 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 May 30, 2002, 15 days after receiving the submission on May 15, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K021589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2002 |
| Decision Date | May 30, 2002 |
| Days to Decision | 15 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 |