CARTO® 3 EP Navigation System With Signal Processing Unit

Computer, Diagnostic, Programmable

Biosense Webster, Inc.

The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto® 3 Ep Navigation System With Signal Processing Unit.

Pre-market Notification Details

• Device ID: K200484
• 510k Number: K200484
• Device Name: CARTO® 3 EP Navigation System With Signal Processing Unit
• Classification: Computer, Diagnostic, Programmable
• Applicant: Biosense Webster, Inc. 33 Technology Drive Irvine, CA 92618
• Contact: Khaled Hamad
• Correspondent: Khaled Hamad; Biosense Webster, Inc. 33 Technology Drive Irvine, CA 92618
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-02-27
• Decision Date: 2020-11-25