NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

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 Noprofile Olbert Catheter System Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK952884
510k NumberK952884
Device Name:NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland,  NJ  07436
ContactStephgen B Anderson
CorrespondentStephgen B Anderson
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland,  NJ  07436
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-23
Decision Date1996-02-21

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