SCOUTPRO HEMOSTATIC VALVE

Catheter, Percutaneous

BIOTRONIK, INC.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Scoutpro Hemostatic Valve.

Pre-market Notification Details

Device IDK101282
510k NumberK101282
Device Name:SCOUTPRO HEMOSTATIC VALVE
ClassificationCatheter, Percutaneous
Applicant BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
ContactJon Brumbaugh
CorrespondentJon Brumbaugh
BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-06
Decision Date2010-07-21
Summary:summary

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