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 IDK012687
510k NumberK012687
Device Name:VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
ClassificationCatheter, Recording, Electrode, Reprocessed
Applicant VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland,  FL  33815
ContactMike Sammon
CorrespondentMike Sammon
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 Received2001-08-14
Decision Date2002-08-01
Summary:summary

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