The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Aspiration Pump, Model 115v.
| Device ID | K051758 |
| 510k Number | K051758 |
| Device Name: | PENUMBRA ASPIRATION PUMP, MODEL 115V |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | PENUMBRA, INC. 2401 MERCED ST., SUITE 200 San Leandro, CA 94577 |
| Contact | Theresa B Brandner-allen |
| Correspondent | Theresa B Brandner-allen PENUMBRA, INC. 2401 MERCED ST., SUITE 200 San Leandro, CA 94577 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-29 |
| Decision Date | 2005-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017952 | K051758 | 000 |
| 00814548012384 | K051758 | 000 |