Data / Medical devices / United States / Biocardia, Inc.

Biocardia, Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 6 510(k) clearances

Name: Biocardia, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biocardia, Inc. is registered with the FDA (registration 3003610571) in Sunnyvale, CA, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 23, 2024. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003610571
Address: 320 Soquel Way, Sunnyvale, CA, United States, 94085
Owner or operator: BioCardia (9038602)
Roles: Manufacturer
First device listed: December 5, 2007
Registered through: 2027
Brand names listed: Avance Steerable Introducer, Morph DNA Steerable Guide Catheter, Morph DNA Steerable Sheath, Morph Sheath Guide, Morph Universal Deflectable Guide Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Diagnostic	DQO	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 23, 2024	K242169	Morph DNA Steerable Introducer Sheath	DYB	Substantially Equivalent	Biocardia	accessdata.fda.gov
January 7, 2020	K192774	BioCardia 8F Morph DNA Deflectable Guide Catheter	DQY	Substantially Equivalent	Biocardia	accessdata.fda.gov
May 6, 2019	K190941	BioCardia 8.5 F Avance Steerable lntroducer	DYB	Substantially Equivalent	Biocardia, Inc.	accessdata.fda.gov
April 15, 2009	K090999	BIOCARDIA MORPH SHEATH GUIDE	DYB	Substantially Equivalent	Biocardia, Inc.	accessdata.fda.gov
February 17, 2005	K042553	BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER	DQY	Substantially Equivalent	Biocardia, Inc.	accessdata.fda.gov
January 24, 2002	K012749	BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664	DQO	Substantially Equivalent	Biocardia, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 3, 2014	67712	Class II	Terminated	Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush	Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.	accessdata.fda.gov
February 7, 2014	67492	Class II	Terminated	MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway thr	Tyvek packaging may be worn, causing loss of package integrity.	accessdata.fda.gov

Compare with other makers

Updated August 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.