K051067 is an FDA 510(k) clearance for the PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT). 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 May 27, 2005, 31 days after receiving the submission on April 26, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K051067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2005 |
| Decision Date | May 27, 2005 |
| Days to Decision | 31 days |
| Submission Type | Special |
| 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 |