Viatrac 14 Plus Peripheral Dilatation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

Abbott Vascular

The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Viatrac 14 Plus Peripheral Dilatation Catheter.

Pre-market Notification Details

Device IDK221057
510k NumberK221057
Device Name:Viatrac 14 Plus Peripheral Dilatation Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant Abbott Vascular 3200 Lakeside Drive Santa Clara,  CA  95054
ContactJiyoung Dang
CorrespondentJiyoung Dang
Abbott Vascular 3200 Lakeside Drive Santa Clara,  CA  95054
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-11
Decision Date2022-05-05

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