Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004824117

FEI Number

3004824117

Entity Name

SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

501 Newton Road, ZJ Hi-Tech Park, Shanghai 201203, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD (Owner Number: 10058792)

Owner / Operator Contact Address

1601 Zhangdong Road, ZJ Hi-Tech Park, Shanghai, CN-SH 201203, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223189

PMA Number

N/A

All Registered Proprietary Names

Firefighter NC Pro PTCA Balloon Catheter Firefighter Pro PTCA Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2023-07-26

Official Correspondent

Siwei Yao

US Agent Details

Zhiqin(Zack) Shen Business: MEDICAL PRODUCT INNOVATION, INC. Email: zack@medicalproductinc.com Phone: (949) 9883515

Related Public Records

Same Entity

SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012693555	SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD	Shanghai, CN
3034695832	SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD	Shanghai, CN

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004824117. Last updated year: 2026. Please use registration number 3004824117 when referencing this establishment in official correspondence.