The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Pica Catheter.
| Device ID | K093970 |
| 510k Number | K093970 |
| Device Name: | PICA CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-01-15 |
| Summary: | summary |