K030398 is an FDA 510(k) clearance for the CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221. This device is classified as a Cannula, Catheter (Class II - Special Controls, product code DQR).
Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on May 23, 2003, 106 days after receiving the submission on February 6, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1300.
| 510(k) Number | K030398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2003 |
| Decision Date | May 23, 2003 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQR — Cannula, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1300 |