AngioSculpt PTA Scoring Baloon Catheters

Catheter, Percutaneous, Cutting/scoring

Spectranetrics

The following data is part of a premarket notification filed by Spectranetrics with the FDA for Angiosculpt Pta Scoring Baloon Catheters.

Pre-market Notification Details

Device IDK150634
510k NumberK150634
Device Name:AngioSculpt PTA Scoring Baloon Catheters
ClassificationCatheter, Percutaneous, Cutting/scoring
Applicant Spectranetrics 9965 Federal Drive Colorado Springs,  CO  80921
ContactKimberley Kline
CorrespondentKimberley Kline
Spectranetics 9965 Federal Drive Colorado Springs,  CO  80921
Product CodePNO  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-11
Decision Date2015-04-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813132022242 K150634 000
00813132022235 K150634 000
00813132022228 K150634 000
00813132022211 K150634 000
00813132022204 K150634 000
00813132022198 K150634 000

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