K200459 is an FDA 510(k) clearance for the pREBOA-PRO Catheter. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by Prytime Medical Devices, Inc. (Boerne, US). The FDA issued a Cleared decision on June 3, 2020, 99 days after receiving the submission on February 25, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K200459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2020 |
| Decision Date | June 03, 2020 |
| Days to Decision | 99 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 |