The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Tdmac-heparin Coated Rmi Carotid By-pass Shunt.
| Device ID | K862634 |
| 510k Number | K862634 |
| Device Name: | TDMAC-HEPARIN COATED RMI 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 | 1986-07-10 |
| Decision Date | 1986-10-31 |