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 |