CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

Catheter, Electrode Recording, Or Probe, Electrode Recording

BIOSENSE WEBSTER, INC.

The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Cs Refstar Catheter (d- And F-curves), Models D-1285-01 And D-1285-02.

Pre-market Notification Details

• Device ID: K080425
• 510k Number: K080425
• Device Name: CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
• Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
• Applicant: BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765
• Contact: Balaka Das
• Correspondent: Balaka Das; BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765
• Product Code: DRF
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-02-15
• Decision Date: 2008-04-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10846835008807	K080425	000
10846835008791	K080425	000
10846835012620	K080425	000
10846835009989	K080425	000
10846835009972	K080425	000