The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Cardiometrics Wavewire/wavemap Pressure System.
| Device ID | K965140 |
| 510k Number | K965140 |
| Device Name: | CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM |
| Classification | Wire, Guide, Catheter |
| Applicant | CARDIOMETRICS, INC. 645 CLYDE AVE. Mountain View, CA 94043 |
| Contact | Erin Dignan |
| Correspondent | Erin Dignan 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 | 1996-12-23 |
| Decision Date | 1997-08-18 |
| Summary: | summary |