The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Flowire 300 And Xt 300 Doppler Guide Wires.
| Device ID | K972762 |
| 510k Number | K972762 |
| Device Name: | CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Claire Andrews |
| Correspondent | Claire Andrews 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 | 1997-07-24 |
| Decision Date | 1997-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00184360000204 | K972762 | 000 |
| 00184360000198 | K972762 | 000 |
| 00184360000167 | K972762 | 000 |
| 00184360000150 | K972762 | 000 |
| 00184360000129 | K972762 | 000 |
| 00184360000112 | K972762 | 000 |