The following data is part of a premarket notification filed by Kerberos Proximal Solutions, Inc. with the FDA for Rinspiration System,rinspiration System Short Tip, Models Fg01477/fg01703.
| Device ID | K041123 |
| 510k Number | K041123 |
| Device Name: | RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | KERBEROS PROXIMAL SOLUTIONS, INC. 1400 TERRA BELLA AVE, SUITE K Mountain View, CA 94043 |
| Contact | Tom Mason |
| Correspondent | Tom Mason KERBEROS PROXIMAL SOLUTIONS, INC. 1400 TERRA BELLA AVE, SUITE K Mountain View, CA 94043 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-30 |
| Decision Date | 2004-08-26 |
| Summary: | summary |