FDA.reportPublic FDA data

BIOCARDIA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036105713003610571BIOCARDIA, INC.1N2026-01-01320 Soquel Way Sunnyvale CA US 94085

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00866749000202Morph Universal Deflectable Guide Catheter - 008956502260120info@biocardia.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
764961473008072K242169Morph DNA Steerable Introducer SheathDYB2024-08-23
764961327684160K192774BioCardia 8F Morph DNA Deflectable Guide CatheterDQY2020-01-07
764961543396029K190941BioCardia 8.5 F Avance Steerable lntroducerDYB2019-05-06
764961666319933K090999BIOCARDIA MORPH SHEATH GUIDEDYB2009-04-15
764961894470494K042553BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETERDQY2005-02-17
764961952295368K012749BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664DQO2002-01-24
764961821947958

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB52024-08-23
DQY42020-01-07
DQO22002-01-24

PMN#

GUDID#