The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System (pennumbra Reperfusion Catheter 054), Model Psc054; (penumbra Separator 054), Model Pss054.
| Device ID | K090752 |
| 510k Number | K090752 |
| Device Name: | PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 |
| Classification | Catheter, Thrombus Retriever |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Contact | Louise Musante |
| Correspondent | Louise Musante PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2009-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017433 | K090752 | 000 |
| 00814548012742 | K090752 | 000 |
| 00814548012759 | K090752 | 000 |
| 00814548012766 | K090752 | 000 |
| 00814548012780 | K090752 | 000 |
| 00814548012797 | K090752 | 000 |
| 00814548012803 | K090752 | 000 |
| 00814548013626 | K090752 | 000 |
| 00814548016771 | K090752 | 000 |
| 00814548017402 | K090752 | 000 |
| 00814548017419 | K090752 | 000 |
| 00814548017426 | K090752 | 000 |
| 00814548010380 | K090752 | 000 |