K201652 is an FDA 510(k) clearance for the COBRA-OS Kit. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by Front Line Medical Technologies, Inc. (London, CA). The FDA issued a Cleared decision on February 22, 2021, 249 days after receiving the submission on June 18, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K201652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | June 18, 2020 |
| Decision Date | February 22, 2021 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MJN - Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |