The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Accutrac Intravascular Guide Wire (modification).
| Device ID | K954913 |
| 510k Number | K954913 |
| Device Name: | CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) |
| Classification | Wire, Guide, Catheter |
| Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Susan E Osborne-noriega |
| Correspondent | Susan E Osborne-noriega CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-03 |
| Decision Date | 1995-11-07 |