ARGYLE HEMATURIA BALLOON CATHETER

Catheter, Urological

SHERWOOD MEDICAL CO.

The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Hematuria Balloon Catheter.

Pre-market Notification Details

• Device ID: K802875
• 510k Number: K802875
• Device Name: ARGYLE HEMATURIA BALLOON CATHETER
• Classification: Catheter, Urological
• Applicant: SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KOD
• CFR Regulation Number: 876.5130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-11-17
• Decision Date: 1980-12-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521015890	K802875	000
30884521016839	K802875	000