The following data is part of a premarket notification filed by Cardiometrics, Inc. with the FDA for Accutrac Xt Intravascular Guide Wire (floppy) Model 2403/(flex) Model 2404.
| Device ID | K961777 |
| 510k Number | K961777 |
| Device Name: | ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 |
| 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 | 1996-05-07 |
| Decision Date | 1996-07-31 |