CARAPACE ANGIOGRAPHY TRAYS

Catheter, Intravascular, Diagnostic

CARAPACE, INC.

The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for Carapace Angiography Trays.

Pre-market Notification Details

Device IDK931629
510k NumberK931629
Device Name:CARAPACE ANGIOGRAPHY TRAYS
ClassificationCatheter, Intravascular, Diagnostic
Applicant CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow,  OK  74012
ContactJerry W Myers
CorrespondentJerry W Myers
CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow,  OK  74012
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-02
Decision Date1993-12-06

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