INTRODUCER SETS, MODEL ADELANTE RADIAL

Introducer, Catheter

Oscor Inc.

The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Introducer Sets, Model Adelante Radial.

Pre-market Notification Details

Device IDK130633
510k NumberK130633
Device Name:INTRODUCER SETS, MODEL ADELANTE RADIAL
ClassificationIntroducer, Catheter
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 CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-11
Decision Date2014-02-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10885672003866 K130633 000
10885672000575 K130633 000

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