ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER

Catheter, Percutaneous

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Attain Clarity 6225 Venogram Balloon Catheter.

Pre-market Notification Details

Device IDK121219
510k NumberK121219
Device Name:ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER
ClassificationCatheter, Percutaneous
Applicant MEDTRONIC INC. 8200 CORAL SEA STREET MS MVSII Mounds View,  MN  55112
ContactWendy Saunders
CorrespondentWendy Saunders
MEDTRONIC INC. 8200 CORAL SEA STREET MS MVSII Mounds View,  MN  55112
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-23
Decision Date2012-09-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169530102 K121219 000
00643169181717 K121219 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.