The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Balloon Guide Catheter, Model 7.5f.
| Device ID | K053491 |
| 510k Number | K053491 |
| Device Name: | PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-15 |
| Decision Date | 2006-04-27 |
| Summary: | summary |