ATTAIN 6215 VENOGRAM BALLOON CATHETER

Catheter, Flow Directed

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Attain 6215 Venogram Balloon Catheter.

Pre-market Notification Details

Device IDK012225
510k NumberK012225
Device Name:ATTAIN 6215 VENOGRAM BALLOON CATHETER
ClassificationCatheter, Flow Directed
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis,  MN  55432 -3576
ContactKaren Reidt
CorrespondentKaren Reidt
MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis,  MN  55432 -3576
Product CodeDYG  
CFR Regulation Number870.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-16
Decision Date2001-08-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994842114 K012225 000
00763000227982 K012225 000

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