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 IDK991878
510k NumberK991878
Device Name:LUMA-CATH STEERABLE EP CATHETERS
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine,  CA  92612
ContactRoger Tu
CorrespondentRoger Tu
IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine,  CA  92612
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-02
Decision Date1999-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414734306294 K991878 000
05414734306249 K991878 000
05414734306218 K991878 000
05414734306201 K991878 000

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