The following data is part of a premarket notification filed by Guidewire Technologies, Inc. with the FDA for Movable Core Guidewire.
Device ID | K902152 |
510k Number | K902152 |
Device Name: | MOVABLE CORE 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 | 1990-05-15 |
Decision Date | 1990-07-31 |