The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Flowire Doppler Guide Wires.
| Device ID | K941485 |
| 510k Number | K941485 |
| Device Name: | CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Susan E Osborne |
| Correspondent | Susan E Osborne 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 | 1994-03-28 |
| Decision Date | 1994-05-31 |