K103356 is an FDA 510(k) clearance for the PRUITT CAROTID KIT. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on December 8, 2010, 22 days after receiving the submission on November 16, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K103356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2010 |
| Decision Date | December 08, 2010 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MJN — Catheter, Intravascular Occluding, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |