Chocolate PTA Balloon Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Chocolate Pta Balloon Catheter.

Pre-market Notification Details

Device IDK213631
510k NumberK213631
Device Name:Chocolate PTA Balloon Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Medtronic, Inc. 2300 Berkshire Lane North, Suite 5 Plymouth,  MN  55441
ContactLaura Hanson
CorrespondentLaura Hanson
Medtronic, Inc. 2300 Berkshire Lane North, Suite 5 Plymouth,  MN  55441
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-17
Decision Date2021-12-15

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