Opticross 35 15 MHz Peripheral Imaging Catheter

Transducer, Ultrasonic, Diagnostic

Boston Scientific Corporation

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Opticross 35 15 Mhz Peripheral Imaging Catheter.

Pre-market Notification Details

Device IDK200733
510k NumberK200733
Device Name:Opticross 35 15 MHz Peripheral Imaging Catheter
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant Boston Scientific Corporation 3 Scimed Place Maple Grove,  MN  55311
ContactJennifer L. Foley
CorrespondentJennifer L. Foley
Boston Scientific Corporation 3 Scimed Place Maple Grove,  MN  55311
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-20
Decision Date2020-04-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08714729984542 K200733 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.