The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Super Torque Mb Angiographic Catheter With Radiopaque Markerbands.
| Device ID | K212977 |
| 510k Number | K212977 |
| Device Name: | SUPER TORQUE MB Angiographic Catheter With Radiopaque Markerbands |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
| Contact | Vidya Venkataraghavan |
| Correspondent | Vidya Venkataraghavan Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-17 |
| Decision Date | 2022-02-17 |