CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085

Catheter, Electrode Recording, Or Probe, Electrode Recording

CORDIS WEBSTER, INC.

The following data is part of a premarket notification filed by Cordis Webster, Inc. with the FDA for Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085.

Pre-market Notification Details

• Device ID: K992965
• 510k Number: K992965
• Device Name: CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
• Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
• Applicant: CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706
• Contact: Mary Adams
• Correspondent: Mary Adams; CORDIS WEBSTER, INC. 4750 LITTLEJOHN ST. Baldwin Park, CA 91706
• Product Code: DRF
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-09-02
• Decision Date: 1999-11-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10846835009996	K992965	000
10846835001624	K992965	000
10846835001648	K992965	000
10846835001655	K992965	000
10846835006889	K992965	000
10846835006896	K992965	000
10846835006902	K992965	000
10846835006919	K992965	000
10846835006933	K992965	000
10846835001594	K992965	000