RUSCH BRILLANT SILICONE FOLEY CATHETER

Catheter, Retention Type, Balloon

RUSCH INTL.

The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Brillant Silicone Foley Catheter.

Pre-market Notification Details

• Device ID: K972184
• 510k Number: K972184
• Device Name: RUSCH BRILLANT SILICONE FOLEY CATHETER
• Classification: Catheter, Retention Type, Balloon
• Applicant: RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452
• Contact: James R Whitney
• Correspondent: James R Whitney; RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452
• Product Code: EZL
• CFR Regulation Number: 876.5130 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-06-10
• Decision Date: 1998-01-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704307979	K972184	000
44026704308031	K972184	000
24026704308020	K972184	000
24026704308013	K972184	000
44026704308000	K972184	000
44026704307997	K972184	000
24026704307986	K972184	000
44026704307966	K972184	000
24026704022131	K972184	000
44026704022128	K972184	000
44026704022111	K972184	000
24026704334883	K972184	000
44026704334870	K972184	000
24026704334869	K972184	000
44026704334856	K972184	000
44026704308048	K972184	000
24026704308051	K972184	000
44026704547300	K972184	000
24026704335071	K972184	000
44026704335068	K972184	000
24026704335057	K972184	000
24026704335040	K972184	000
44026704335037	K972184	000
24026704335026	K972184	000
24026704335019	K972184	000
44026704335006	K972184	000
44026704334993	K972184	000
24026704334982	K972184	000
44026704334979	K972184	000
24026704334968	K972184	000
44026704334955	K972184	000
24026704105711	K972184	000