The Caterpillar And Caterpillar Micro Arterial Embolization Devices

Device, Vascular, For Promoting Embolization

C. R. Bard, Inc.

The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for The Caterpillar And Caterpillar Micro Arterial Embolization Devices.

Pre-market Notification Details

Device IDK191532
510k NumberK191532
Device Name:The Caterpillar And Caterpillar Micro Arterial Embolization Devices
ClassificationDevice, Vascular, For Promoting Embolization
Applicant C. R. Bard, Inc. Moyne Upper Emniscorthy,  IE
ContactMelanie Hadlock
CorrespondentMelanie Hadlock
C. R. Bard, Inc. Moyne Upper Emniscorthy,  IE
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-10
Decision Date2020-02-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00801741175565 K191532 000
00801741155307 K191532 000

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