Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024801436

FEI Number

3024801436

Entity Name

SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CORPORATION LIMITED

City/State/Country

Shanghai, CN

Establishment Address

Building 38, No.356 Zhengbo Road, LIN-GANG Special Area, China(Shanghai) Pilot Free Trade Zone, 201422 Shanghai, China, Shanghai 201422, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai HeartCare Medical Technology Corporation Limited (Owner Number: 10087291)

Owner / Operator Contact Address

Building 38, No.356 Zhengbo Road, LIN-GANG Special Area, China(Shanghai) Pilot Free Trade Zone, 201422, Shangh, Shanghai, CN-SH 201422, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202926

PMA Number

N/A

All Registered Proprietary Names

Distal Access Catheter Balloon Guiding Catheter Micro Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-03-07
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-03-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-02-09
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-02-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-02-09
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-02-09

Official Correspondent

Tianrong Hong

US Agent Details

Zhigang Li Business: 3V MEDICAL, INC. Email: Jackli@heartcare.com.cn Phone: (949) 7382361

Related Public Records

Same Entity

Shanghai HeartCare Medical Technology Corporation Limited

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
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
3039062605	CORVITEX CORPORATION	Raleigh, NC, US
3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3011142981	Rontis Hellas S.A.	Larisa Thessalia, GR
3010370269	STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD	Cape Town Western Cape, ZA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024801436. Last updated year: 2026. Please use registration number 3024801436 when referencing this establishment in official correspondence.