ANGIOGRAPHIC CATHETER, MODEL ANGIOS

Catheter, Intravascular, Diagnostic

Oscor Inc.

The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Angiographic Catheter, Model Angios.

Pre-market Notification Details

Device IDK092118
510k NumberK092118
Device Name:ANGIOGRAPHIC CATHETER, MODEL ANGIOS
ClassificationCatheter, Intravascular, Diagnostic
Applicant Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor,  FL  34683
ContactMila Doskocil
CorrespondentMila Doskocil
Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor,  FL  34683
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-14
Decision Date2010-01-13

NIH GUDID Devices

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