IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

Catheter, Electrode Recording, Or Probe, Electrode Recording

IRVINE BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Irvine Biomedical, Inc. with the FDA for Ibi-1100 Steerable Electrophysiology Catheter System.

Pre-market Notification Details

• Device ID: K961924
• 510k Number: K961924
• Device Name: IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM
• Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
• Applicant: IRVINE BIOMEDICAL, INC. 214A MICHELSON DR. Irvine, CA 92715
• Contact: Peter Chen
• Correspondent: Peter Chen; IRVINE BIOMEDICAL, INC. 214A MICHELSON DR. Irvine, CA 92715
• Product Code: DRF
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-17
• Decision Date: 1997-04-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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