The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Flowire Doppler Guide Wire.
Device ID | K943022 |
510k Number | K943022 |
Device Name: | CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE |
Classification | Wire, Guide, Catheter |
Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
Contact | Susan O Noriega |
Correspondent | Susan O 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 | 1994-06-24 |
Decision Date | 1994-09-19 |