The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Embolectomy Aspiration System.
| Device ID | K121917 |
| 510k Number | K121917 |
| Device Name: | PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM |
| Classification | Catheter, Embolectomy |
| 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 | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2012-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548016122 | K121917 | 000 |
| 00815948020542 | K121917 | 000 |
| 00814548013299 | K121917 | 000 |
| 00814548013305 | K121917 | 000 |
| 00814548013312 | K121917 | 000 |
| 00814548013329 | K121917 | 000 |
| 00814548013336 | K121917 | 000 |
| 00814548016047 | K121917 | 000 |
| 00814548016054 | K121917 | 000 |
| 00814548016061 | K121917 | 000 |
| 00814548016078 | K121917 | 000 |
| 00814548016085 | K121917 | 000 |
| 00814548016092 | K121917 | 000 |
| 00814548016108 | K121917 | 000 |
| 00814548016115 | K121917 | 000 |
| 00815948020535 | K121917 | 000 |