The following data is part of a premarket notification filed by Kerberos Proximal Solutions, Inc. with the FDA for Rinspiration Catheter System, Models 50135, 550135, P7065, P70135.
| Device ID | K062275 |
| 510k Number | K062275 |
| Device Name: | RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135 |
| Classification | Catheter, Embolectomy |
| Applicant | KERBEROS PROXIMAL SOLUTIONS, INC. 10600 NORTH TANTAU AVE. Cupertino, CA 95014 |
| Contact | Tom Mason |
| Correspondent | Tom Mason KERBEROS PROXIMAL SOLUTIONS, INC. 10600 NORTH TANTAU AVE. Cupertino, CA 95014 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-07 |
| Decision Date | 2006-09-20 |
| Summary: | summary |