The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Ddc Catheters.
| Device ID | K122772 |
| 510k Number | K122772 |
| Device Name: | PENUMBRA DDC CATHETERS |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-10 |
| Decision Date | 2012-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548013275 | K122772 | 000 |
| 00814548012674 | K122772 | 000 |
| 00814548012667 | K122772 | 000 |