K152833 is an FDA 510(k) clearance for the Pruitt F3-S Polyurethane Carotid Shunt. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on January 21, 2016, 114 days after receiving the submission on September 29, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K152833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2015 |
| Decision Date | January 21, 2016 |
| Days to Decision | 114 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 |