Passeo-18 Peripheral Dilation Catheter

Catheter, Angioplasty, Peripheral, Transluminal

BIOTRONIK, INC.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Passeo-18 Peripheral Dilation Catheter.

Pre-market Notification Details

Device IDK151744
510k NumberK151744
Device Name:Passeo-18 Peripheral Dilation Catheter
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
ContactJon Brumbaugh
CorrespondentJon Brumbaugh
BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-29
Decision Date2015-10-08
Summary:summary

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