The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Catherer 025.
| Device ID | K100826 |
| 510k Number | K100826 |
| Device Name: | PENUMBRA CATHERER 025 |
| Classification | Catheter, Percutaneous |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Contact | Seth A Schulman |
| Correspondent | Seth A Schulman PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-24 |
| Decision Date | 2010-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548016450 | K100826 | 000 |
| 00814548012568 | K100826 | 000 |
| 00814548012551 | K100826 | 000 |
| 00814548012537 | K100826 | 000 |
| 00814548012520 | K100826 | 000 |
| 00814548012513 | K100826 | 000 |
| 00814548012506 | K100826 | 000 |
| 00814548011653 | K100826 | 000 |
| 00814548011646 | K100826 | 000 |
| 00814548011639 | K100826 | 000 |
| 00814548011622 | K100826 | 000 |
| 00814548010465 | K100826 | 000 |
| 00814548012575 | K100826 | 000 |
| 00814548012582 | K100826 | 000 |
| 00814548012599 | K100826 | 000 |
| 00814548016443 | K100826 | 000 |
| 00814548016436 | K100826 | 000 |
| 00814548016429 | K100826 | 000 |
| 00814548016412 | K100826 | 000 |
| 00814548016405 | K100826 | 000 |
| 00814548012650 | K100826 | 000 |
| 00814548012643 | K100826 | 000 |
| 00814548012636 | K100826 | 000 |
| 00814548012629 | K100826 | 000 |
| 00814548012612 | K100826 | 000 |
| 00814548012605 | K100826 | 000 |
| 00814548010342 | K100826 | 000 |