HEMOCATH

Cannula, A-v Shunt

QUINTON, INC.

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

Pre-market Notification Details

• Device ID: K840415
• 510k Number: K840415
• Device Name: HEMOCATH
• Classification: Cannula, A-v Shunt
• Applicant: QUINTON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: FIQ
• CFR Regulation Number: 876.5540 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-01-31
• Decision Date: 1984-04-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521009813	K840415	000