K915869 is an FDA 510(k) clearance for the RMI NORMOCLUDER CORONARY ARTERY OCCLUDER. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on December 8, 1992, 343 days after receiving the submission on December 31, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K915869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 1991 |
| Decision Date | December 08, 1992 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MJN — Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |