The following data is part of a premarket notification filed by Kerberos Proximal Solutions, Inc. with the FDA for Kerberos Proximal Solutions Rispiration System.
| Device ID | K050130 |
| 510k Number | K050130 |
| Device Name: | KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-21 |
| Decision Date | 2005-05-13 |
| Summary: | summary |