CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE

Laparoscope, General & Plastic Surgery

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cardioblate Navigator Tissue Dissection Device.

Pre-market Notification Details

Device IDK062727
510k NumberK062727
Device Name:CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
ClassificationLaparoscope, General & Plastic Surgery
Applicant MEDTRONIC VASCULAR 7601 NORTHLAND DRIVE Brooklyn Park,  MN  55428 -1088
ContactScott Candy
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-09-13
Decision Date2006-10-11
Summary:summary

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