K212977 is an FDA 510(k) clearance for the SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Cordis Corporation (Miami Lakes, US). The FDA issued a Cleared decision on February 17, 2022, 153 days after receiving the submission on September 17, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K212977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2021 |
| Decision Date | February 17, 2022 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |