VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES

Cable, Transducer And Electrode, Patient, (including Connector)

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 Catheter Accessory Cables.

Pre-market Notification Details

Device IDK030005
510k NumberK030005
Device Name:VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
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 CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-02
Decision Date2003-03-18
Summary:summary

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