GUIDEWIRE

Wire, Guide, Catheter

GALT MEDICAL CORP.

The following data is part of a premarket notification filed by Galt Medical Corp. with the FDA for Guidewire.

Pre-market Notification Details

• Device ID: K982559
• 510k Number: K982559
• Device Name: GUIDEWIRE
• Classification: Wire, Guide, Catheter
• Applicant: GALT MEDICAL CORP. 2475 MERRITT DR. Garland, TX 75041
• Contact: Jim Edings
• Correspondent: Jim Edings; GALT MEDICAL CORP. 2475 MERRITT DR. Garland, TX 75041
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-07-23
• Decision Date: 1999-02-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841268109626	K982559	000
00841268100572	K982559	000
00841268100589	K982559	000
00841268100596	K982559	000
00841268100602	K982559	000
00841268100619	K982559	000
00841268100626	K982559	000
00841268100633	K982559	000
00841268100640	K982559	000
00841268100565	K982559	000
00841268100558	K982559	000
00841268100541	K982559	000
10841268109671	K982559	000
10841268109688	K982559	000
10841268109695	K982559	000
10841268109701	K982559	000
10841268109718	K982559	000
00841268100435	K982559	000
00841268100527	K982559	000
00841268100534	K982559	000
00841268100657	K982559	000
00841268100664	K982559	000
00841268100787	K982559	000
00841268100794	K982559	000
00841268100800	K982559	000
00841268100817	K982559	000
00841268100824	K982559	000
00841268100831	K982559	000
00841268100848	K982559	000
20841268107346	K982559	000
00841268100770	K982559	000
00841268100763	K982559	000
00841268100756	K982559	000
00841268100671	K982559	000
00841268100688	K982559	000
00841268100695	K982559	000
00841268100701	K982559	000
00841268100718	K982559	000
00841268100725	K982559	000
00841268100732	K982559	000
00841268100749	K982559	000
20841268108428	K982559	000