GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER

Catheter, Angioplasty, Peripheral, Transluminal

NORTH AMERICAN INSTRUMENT CORP.

The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Guidewire Torque Device And Guidewire Introducer.

Pre-market Notification Details

• Device ID: K903606
• 510k Number: K903606
• Device Name: GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801
• Contact: Robert E Franklin
• Correspondent: Robert E Franklin; NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801
• Product Code: LIT
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-07-30
• Decision Date: 1990-09-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H965914004001	K903606	000
H965914003001	K903606	000
10193489087796	K903606	000
10193489068009	K903606	000
10193489067149	K903606	000
20193489069348	K903606	000
20193489069331	K903606	000
H965800450750	K903606	000