SPYSCOPE ACCESS AND DELIVERY CATHETER

Mini Endoscope, Gastroenterology-urology

BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Spyscope Access And Delivery Catheter.

Pre-market Notification Details

Device IDK090170
510k NumberK090170
Device Name:SPYSCOPE ACCESS AND DELIVERY CATHETER
ClassificationMini Endoscope, Gastroenterology-urology
Applicant BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough,  MA  01752
ContactAshley Pyle
CorrespondentJay Y Kogoma
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeODF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-01-23
Decision Date2009-02-04
Summary:summary

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