Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014254831

FEI Number

3014254831

Entity Name

Quasar Electronics Technology (Dongguan) Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Bldg 8 of Guantai Biotech Technical Cooperation center Taoyuan 1st Rd, Taiwan High Tech Park of High and New tech Development Zone of Songshan Lake, Dongguan Guangdong 523808, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Quasar Engineering Ltd. (Owner Number: 10025822)

Owner / Operator Contact Address

Flat B1, 10/F, Yeung Yiu Chung No.6 Industrial Bldg, 19 Cheung Shun St, Cheung Sha Wan, Kowloon, HK-NOTA NONE, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Auryon Atherectomy System OR Auryon Atherecomy Catheter Auryon Atherectomy System OR Auryon Atherecomy Catheter Auryon Atherectomy System OR Auryon Atherecomy Catheter Auryon Atherectomy System OR Auryon Atherecomy Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2024-03-19
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-07-08
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2023-09-19
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2023-06-23

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

Quasar Engineering 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
3017844574	Quasar Medical (Thailand) Co., Ltd	Chonburi Chon Buri, TH
3007048256	QUASAR ENGINEERING LTD.	Kowloon, HK

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014254831. Last updated year: 2026. Please use registration number 3014254831 when referencing this establishment in official correspondence.