ULTRA-CBX

Device, Biopsy, Endomyocardial

MEDCANICA, INC.

The following data is part of a premarket notification filed by Medcanica, Inc. with the FDA for Ultra-cbx.

Pre-market Notification Details

Device IDK991486
510k NumberK991486
Device Name:ULTRA-CBX
ClassificationDevice, Biopsy, Endomyocardial
Applicant MEDCANICA, INC. 19526 EAST LAKE DR. Miami,  FL  33015
ContactAl Weisenborn
CorrespondentAl Weisenborn
MEDCANICA, INC. 19526 EAST LAKE DR. Miami,  FL  33015
Product CodeDWZ  
CFR Regulation Number870.4075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-28
Decision Date1999-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05415067009579 K991486 000
05415067009562 K991486 000
05415067009555 K991486 000
05415067009548 K991486 000
05415067009531 K991486 000
05415067009524 K991486 000
05415067009517 K991486 000

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