The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Balloon-occlusive Carotid By-pass Shunt.
Device ID | K861790 |
510k Number | K861790 |
Device Name: | RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
Contact | Michael N Kelly |
Correspondent | Michael N Kelly RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-09 |
Decision Date | 1986-07-21 |