PATHFINDER

Catheter, Electrode Recording, Or Probe, Electrode Recording

CARDIMA, INC.

The following data is part of a premarket notification filed by Cardima, Inc. with the FDA for Pathfinder.

Pre-market Notification Details

• Device ID: K955802
• 510k Number: K955802
• Device Name: PATHFINDER
• Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
• Applicant: CARDIMA, INC. 47266 BENICIA ST. P.O. BOX 14172 Fremont, CA 94539 -1372
• Contact: Gabriel Vegh
• Correspondent: Gabriel Vegh; CARDIMA, INC. 47266 BENICIA ST. P.O. BOX 14172 Fremont, CA 94539 -1372
• Product Code: DRF
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-12-22
• Decision Date: 1997-01-29
• Summary: summary