The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Ace.
| Device ID | K142458 |
| 510k Number | K142458 |
| Device Name: | Penumbra System ACE |
| Classification | Catheter, Thrombus Retriever |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Contact | Michaela Mahl |
| Correspondent | Michaela Mahl PENUMBRA, INC. 1351 HARBOR BAY PARKWAY 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 | 2014-09-02 |
| Decision Date | 2015-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017532 | K142458 | 000 |
| 00814548016498 | K142458 | 000 |
| 00814548016481 | K142458 | 000 |
| 00814548016467 | K142458 | 000 |
| 00814548016207 | K142458 | 000 |
| 00814548016191 | K142458 | 000 |
| 00814548016184 | K142458 | 000 |
| 00814548016177 | K142458 | 000 |
| 00814548016160 | K142458 | 000 |
| 00814548014005 | K142458 | 000 |
| 00814548013992 | K142458 | 000 |
| 00814548013985 | K142458 | 000 |
| 00814548013978 | K142458 | 000 |
| 00814548013961 | K142458 | 000 |
| 00815948022850 | K142458 | 000 |
| 00814548016504 | K142458 | 000 |
| 00814548016511 | K142458 | 000 |
| 00814548017525 | K142458 | 000 |
| 00814548017518 | K142458 | 000 |
| 00814548017501 | K142458 | 000 |
| 00814548017495 | K142458 | 000 |
| 00814548017488 | K142458 | 000 |
| 00814548016603 | K142458 | 000 |
| 00814548016597 | K142458 | 000 |
| 00814548016580 | K142458 | 000 |
| 00814548016573 | K142458 | 000 |
| 00814548016566 | K142458 | 000 |
| 00814548016559 | K142458 | 000 |
| 00814548016542 | K142458 | 000 |
| 00814548016535 | K142458 | 000 |
| 00814548016528 | K142458 | 000 |
| 00815948022843 | K142458 | 000 |