Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027343398

FEI Number

3027343398

Entity Name

DK Medical Technology Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Unit301, 303,305 and 311 bioBAY B1 Building, 218 Xinghu Str., Suzhou Industrial Park, Suzhou, Jiangsu, 215123, #5 Building, Xinhong Industrial Park, #9 Suhong West Rd., Suzhou Industrial Park, Suzhou, Jiangsu, 215000, Suzhou Jiangsu 215123, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DK Medical Technology Co., Ltd. (Owner Number: 10087839)

Owner / Operator Contact Address

Unit 301, 303,305 and 311 bioBAY B1 Building, 218 Xinghu Str., Suzhou Industrial Park, Suzhou, Jiangsu, #5 Building, Xinhong Industrial Park, #9 Suhong West Rd., Suzhou Industrial Park, Suzhou, Jiangsu, Suzhou, CN-JS 215123, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232207

PMA Number

N/A

All Registered Proprietary Names

Peripheral Scoring Balloon Dilatation Catheter D·Kutting PTA Scoring Balloon Dilatation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2025-04-29
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2024-03-13

Official Correspondent

Quan Shi

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

DK Medical Technology Co., Ltd.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027343398. Last updated year: 2026. Please use registration number 3027343398 when referencing this establishment in official correspondence.