The following data is part of a premarket notification filed by Guidewire Technologies, Inc. with the FDA for Teflon Coated Guidewire.
| Device ID | K902153 |
| 510k Number | K902153 |
| Device Name: | TEFLON COATED GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDEWIRE TECHNOLOGIES, INC. 10 LAWRENCE RD. Salem, NH 03079 |
| Contact | Douglas J Curtis |
| Correspondent | Douglas J Curtis GUIDEWIRE TECHNOLOGIES, INC. 10 LAWRENCE RD. Salem, NH 03079 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-07-31 |