K141762 is an FDA 510(k) clearance for the PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 27, 2014, 57 days after receiving the submission on July 1, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K141762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2014 |
| Decision Date | August 27, 2014 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |