LUMA-CATH STEERABLE EP CATHETERS

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 Luma-cath Steerable Ep Catheters.

Pre-market Notification Details

• Device ID: K991878
• 510k Number: K991878
• Device Name: LUMA-CATH STEERABLE EP CATHETERS
• Classification: Catheter, Electrode Recording, Or Probe, Electrode Recording
• Applicant: IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine, CA 92612
• Contact: Roger Tu
• Correspondent: Roger Tu; IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine, CA 92612
• Product Code: DRF
• CFR Regulation Number: 870.1220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-02
• Decision Date: 1999-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05414734306294	K991878	000
05414734306249	K991878	000
05414734306218	K991878	000
05414734306201	K991878	000