The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Separator Flex (026,032,041,054), Models Psf026, Psf032, Psf041, Psf054.
| Device ID | K100769 |
| 510k Number | K100769 |
| Device Name: | PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054 |
| Classification | Catheter, Thrombus Retriever |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Contact | Michaela Mahl |
| Correspondent | Michaela Mahl PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-18 |
| Decision Date | 2010-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548010434 | K100769 | 000 |
| 00814548010427 | K100769 | 000 |
| 00814548010410 | K100769 | 000 |
| 00814548010403 | K100769 | 000 |
| 00814548010328 | K100769 | 000 |