GUIDEWIRE

Wire, Guide, Catheter

GUIDEWIRE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Guidewire Technologies, Inc. with the FDA for Guidewire.

Pre-market Notification Details

• Device ID: K890959
• 510k Number: K890959
• Device Name: 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: 1989-02-27
• Decision Date: 1989-09-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50888439503485	K890959	000