K960098 is an FDA 510(k) clearance for the RMI INTERNAL MAMMARY ARTERY CANNULA. This device is classified as a Cannula, Catheter (Class II - Special Controls, product code DQR).
Submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on March 26, 1996, 75 days after receiving the submission on January 11, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1300.
| 510(k) Number | K960098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1996 |
| Decision Date | March 26, 1996 |
| Days to Decision | 75 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 |