K960715 is an FDA 510(k) clearance for the PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F. This device is classified as a Catheter, Intravascular Occluding, Temporary (Class II - Special Controls, product code MJN).
Submitted by Ideas For Medicine, Inc. (Clearwater, US). The FDA issued a Cleared decision on September 9, 1996, 201 days after receiving the submission on February 21, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K960715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1996 |
| Decision Date | September 09, 1996 |
| Days to Decision | 201 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 |