PENUMBRA SYSTEM
Catheter, Thrombus Retriever
PENUMBRA, INC.
The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System.
Pre-market Notification Details
| Device ID | K072718 |
| 510k Number | K072718 |
| Device Name: | PENUMBRA SYSTEM |
| Classification | Catheter, Thrombus Retriever |
| Applicant | PENUMBRA, INC. 2401 MERCED ST., SUITE 200 San Leandro, CA 94577 |
| Contact | Theresa Brandner-allen |
| Correspondent | Theresa Brandner-allen PENUMBRA, INC. 2401 MERCED ST., SUITE 200 San Leandro, CA 94577 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-25 |
| Decision Date | 2007-12-28 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548010373 | K072718 | 000 |
| 00814548010366 | K072718 | 000 |
| 00814548010359 | K072718 | 000 |
| 00814548010311 | K072718 | 000 |
| 00814548010304 | K072718 | 000 |
Trademark Results [PENUMBRA SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PENUMBRA SYSTEM 86627488 4996044 Live/Registered |
Penumbra, Inc. 2015-05-12 |
 PENUMBRA SYSTEM 78890229 3633499 Live/Registered |
Penumbra, Inc. 2006-05-23 |
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