The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometics Flowire, Smartwire Doppler Guide Wire.
| Device ID | K951567 |
| 510k Number | K951567 |
| Device Name: | CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Michael J Billig |
| Correspondent | Michael J Billig CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-04 |
| Decision Date | 1996-10-25 |
| Summary: | summary |