VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

Catheter, Recording, Electrode, Reprocessed

VANGUARD MEDICAL CONCEPTS, INC.

The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed Diagnostic Electrophysiology Catheters.

Pre-market Notification Details

Device IDK051043
510k NumberK051043
Device Name:VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
ClassificationCatheter, Recording, Electrode, Reprocessed
Applicant VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland,  FL  33815
ContactHeather Crawford
CorrespondentHeather Crawford
VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland,  FL  33815
Product CodeNLH  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-25
Decision Date2005-06-06
Summary:summary

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