Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010391265

FEI Number

3010391265

Entity Name

BROSMED MEDICAL CO.,LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone, Dongguan Guangdong 523808, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Brosmed Medical Co.,Ltd (Owner Number: 10044695)

Owner / Operator Contact Address

15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone, Dongguan, CN-GD 523808, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212215

PMA Number

N/A

All Registered Proprietary Names

Balloon Inflation Device SABER 14 PTA Dilatation Catheter; SABERX 14 PTA Dilatation Catheter Apollo Balloon Dilatation Catheter Aperi NC Balloon Dilatation Catheter Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters

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	2014-09-16
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2023-12-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2023-06-14
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2023-04-17
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2016-08-15
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2017-02-27
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2024-11-04
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2025-03-10
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2022-07-20

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Brosmed Medical 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

Similar Registrations

Registration Number	Establishment Name	Location
9614654	Kaneka Corporation Osaka Plant	Settsu-shi Osaka, JP
3010273872	Synergy Health AST, SRL	Alajuela, CR
3007836437	HOSMED INC.	Doral, FL, US
9681260	Boston Scientific Limited	GALWAY, IE
2124215	Boston Scientific Corporation	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010391265. Last updated year: 2026. Please use registration number 3010391265 when referencing this establishment in official correspondence.