The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Max.
| Device ID | K113163 |
| 510k Number | K113163 |
| Device Name: | PENUMBRA SYSTEM MAX |
| Classification | Catheter, Thrombus Retriever |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda, CA 94502 |
| Contact | Seth Schulman |
| Correspondent | Seth Schulman PENUMBRA, INC. 1351 HARBOR BAY PARKWAY 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 | 2011-10-26 |
| Decision Date | 2011-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548019956 | K113163 | 000 |
| 00814548012407 | K113163 | 000 |
| 00814548012391 | K113163 | 000 |
| 00814548012025 | K113163 | 000 |
| 00815948020115 | K113163 | 000 |
| 00815948020108 | K113163 | 000 |
| 00815948020092 | K113163 | 000 |
| 00815948020085 | K113163 | 000 |
| 00815948020078 | K113163 | 000 |
| 00815948020061 | K113163 | 000 |
| 00814548012414 | K113163 | 000 |
| 00814548012483 | K113163 | 000 |
| 00814548019949 | K113163 | 000 |
| 00814548019932 | K113163 | 000 |
| 00814548019802 | K113163 | 000 |
| 00814548019796 | K113163 | 000 |
| 00814548019741 | K113163 | 000 |
| 00814548019734 | K113163 | 000 |
| 00814548016757 | K113163 | 000 |
| 00814548016740 | K113163 | 000 |
| 00814548012490 | K113163 | 000 |
| 00814548019963 | K113163 | 000 |