BioCardia 8F Morph DNA Deflectable Guide Catheter

Catheter, Percutaneous

BioCardia

The following data is part of a premarket notification filed by Biocardia with the FDA for Biocardia 8f Morph Dna Deflectable Guide Catheter.

Pre-market Notification Details

Device IDK192774
510k NumberK192774
Device Name:BioCardia 8F Morph DNA Deflectable Guide Catheter
ClassificationCatheter, Percutaneous
Applicant BioCardia 125 Shoreway Road, Suite B San Carlos,  CA  94070
ContactPatrick Lee
CorrespondentPatrick Lee
BioCardia 125 Shoreway Road, Suite B San Carlos,  CA  94070
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-01-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00866749000295 K192774 000

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