Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014390222

FEI Number

3014390222

Entity Name

KOSSEL MEDTECH (SUZHOU) CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

BLDG 6, No.8 Jinfeng Road, Suzhou New District, 215163 P.R. China, Suzhou Jiangsu 215163, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kossel Medtech (Suzhou) Co., Ltd. (Owner Number: 10061920)

Owner / Operator Contact Address

BLDG 6, No.8 Jinfeng Road, Suzhou New District, 215163 P.R. China, Suzhou, CN-JS 215163, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211393

PMA Number

N/A

All Registered Proprietary Names

Selebrek PTCA Balloon Dilatation Catheter Falspeed PTA Balloon Dilatation Catheter Selethru PTCA Balloon Dilatation Catheter Selepump Inflation Device Falexpand HP PTA Balloon Dilatation Catheter Selethru NC PTCA Balloon Dilatation 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	2022-07-06
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2023-01-16
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2019-12-03
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2020-04-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-01-05
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2021-09-10

Official Correspondent

Zane Wang

US Agent Details

Bryan Wong Business: PUREVISION AI, INC (DBA PURE GLOBAL) Email: us-agent@pureglobal.com Phone: (888) 7681688

Related Public Records

Same Entity

Kossel Medtech (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
K171251	Creagh Medical	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2017-09-08
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K252512	ABBOTT MEDICAL	Armada 14 NC PTA Catheter	2026-02-13
K142654	Covidien, LLC	Fortrex 0.035 OTW PTA Balloon Catheter	2014-10-28
K202800	Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)	Pacific Plus PTA Catheter	2020-11-18

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 3014390222. Last updated year: 2026. Please use registration number 3014390222 when referencing this establishment in official correspondence.