The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardi0metrics Flow Wire Xt Doppler Guide Model 1403, 1404.
| Device ID | K955551 |
| 510k Number | K955551 |
| Device Name: | CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 |
| Classification | Wire, Guide, Catheter |
| Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Michael Billig |
| Correspondent | Michael Billig 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 | 1995-12-05 |
| Decision Date | 1996-02-28 |