Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003610571

FEI Number

3003610571

Entity Name

BIOCARDIA, INC.

City/State/Country

Sunnyvale, CA, US

Establishment Address

320 Soquel Way, Sunnyvale, CA 94085, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioCardia (Owner Number: 9038602)

Owner / Operator Contact Address

320 Soquel Way, Sunnyvale, CA 94085, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042553

PMA Number

N/A

All Registered Proprietary Names

Morph Universal Deflectable Guide Catheter Morph DNA Steerable Sheath Avance Steerable Introducer Morph Universal Deflectable Guide Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-11-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-01-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-09-09

Official Correspondent

Peter Altman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioCardia

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
9616683	TELEFLEX MEDICAL	ANNACOTTY Limerick, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003610571. Last updated year: 2026. Please use registration number 3003610571 when referencing this establishment in official correspondence.