Worker Guidewire

Wire, Guide, Catheter

ARGON MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Argon Medical Devices, Inc. with the FDA for Worker Guidewire.

Pre-market Notification Details

• Device ID: K160785
• 510k Number: K160785
• Device Name: Worker Guidewire
• Classification: Wire, Guide, Catheter
• Applicant: ARGON MEDICAL DEVICES, INC. 1445 FLAT CREEK ROAD Athens, TX 75751
• Contact: Suzanne Cheang
• Correspondent: Suzanne Cheang; ARGON MEDICAL DEVICES, INC. 1445 FLAT CREEK ROAD Athens, TX 75751
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-22
• Decision Date: 2016-12-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20886333224580	K160785	000
20886333008043	K160785	000
20886333008050	K160785	000
20886333008067	K160785	000
20886333008074	K160785	000
20886333008081	K160785	000
20886333008098	K160785	000
20886333008104	K160785	000
20886333008111	K160785	000
20886333008036	K160785	000
20886333008029	K160785	000
20886333007923	K160785	000
20886333007930	K160785	000
20886333007961	K160785	000
20886333007978	K160785	000
20886333007985	K160785	000
20886333007992	K160785	000
20886333008005	K160785	000
20886333008012	K160785	000
20886333008128	K160785	000
20886333224399	K160785	000
20886333224504	K160785	000
20886333224511	K160785	000
20886333224528	K160785	000
20886333224535	K160785	000
20886333224542	K160785	000
20886333224559	K160785	000
20886333224566	K160785	000
20886333224573	K160785	000
20886333224498	K160785	000
20886333224481	K160785	000
20886333224405	K160785	000
20886333224412	K160785	000
20886333224429	K160785	000
20886333224436	K160785	000
20886333224443	K160785	000
20886333224450	K160785	000
20886333224467	K160785	000
20886333224474	K160785	000
20886333007916	K160785	000