The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Normocluder Coronary Artery Occluder.
| Device ID | K915869 |
| 510k Number | K915869 |
| Device Name: | RMI NORMOCLUDER CORONARY ARTERY OCCLUDER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Rd Hubbert |
| Correspondent | Rd Hubbert RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-31 |
| Decision Date | 1992-12-08 |