K051758 is an FDA 510(k) clearance for the PENUMBRA ASPIRATION PUMP, MODEL 115V. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Penumbra, Inc. (San Leandro, US). The FDA issued a Cleared decision on August 17, 2005, 49 days after receiving the submission on June 29, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K051758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2005 |
| Decision Date | August 17, 2005 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | BTA — Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |