Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018070217

FEI Number

3018070217

Entity Name

SHANGHAI ACHIEVA MEDICAL SUZHOU CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.8 Zhongtian Alley, Suzhou Industrial Park,Suzhou Jiangsu, 215028, China, No.133 Fangzhong Street, Suzhou Industrial Park,Suzhou, Jiangsu, 215028, China, Suzhou Jiangsu 215028, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Achieva Medical Suzhou Co., Ltd. (Owner Number: 10095724)

Owner / Operator Contact Address

No.8 Zhongtian Alley, Suzhou Industrial Park,Suzhou Jiangsu, 215028, China, No.133 Fangzhong Street, Suzhou Industrial Park,Suzhou, Jiangsu, 215028, China, Suzhou, CN-JS 215028, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252122

PMA Number

N/A

All Registered Proprietary Names

DCwire Micro-guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2026-04-20
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2026-04-20

Official Correspondent

Jinwei Yi

US Agent Details

Weian Huang Business: JOYSUN USA LLC Email: weian@isosh.com Phone: (949) 4624543

Related Public Records

Same Entity

Shanghai Achieva Medical Suzhou Co., Ltd.

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
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Similar Registrations

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3024743081	EMBRACE MEDICAL LTD.	Tel Aviv, IL
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3015522130	NANO4IMAGING USA, LLC.	Dublin, OH, US
3007635982	Confluent Medical Technologies, Inc	Fremont, CA, US
1225687	Boston Scientific Corp., Marina Bay Cust. Fulfillment Center	QUINCY, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018070217. Last updated year: 2026. Please use registration number 3018070217 when referencing this establishment in official correspondence.