AMPLANTZ AND BENTSON GUIDEWIRES

Wire, Guide, Catheter

MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Amplantz And Bentson Guidewires.

Pre-market Notification Details

Device IDK912798
510k NumberK912798
Device Name:AMPLANTZ AND BENTSON GUIDEWIRES
ClassificationWire, Guide, Catheter
Applicant MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland,  NJ  07436
ContactPatricia Christian
CorrespondentPatricia Christian
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland,  NJ  07436
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-25
Decision Date1991-09-23

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