Data / Medical devices / Hong Kong / Quasar Engineering Ltd.
Quasar Engineering Ltd.: FDA-registered device maker in Kowloon, Hong Kong, 10 510(k) clearances
Quasar Engineering Ltd. is registered with the FDA (registration 3007048256) in Kowloon, Hong Kong. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007048256
- Address
- Flat B1, 10/F, Yeung Yiu Chung No.6 Industrial Bldg 19 Cheung Shun St, Cheung Sha Wan, Kowloon, Hong Kong, NONE
- Owner or operator
- Quasar Engineering Ltd. (10025822)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- May 12, 2008
- Registered through
- 2027
- Brand names listed
- Advance Adult Oral-Nasal Filter Line With O2 Tubing/Microstream Luer Adult Oral-Nasal Sampling Line, Advance Pediatric Oral-Nasal Filter Line With O2 Tubing/Microstream, Auryon Atherectomy System OR Auryon Atherecomy Catheter, Cuff Pressure Manometer, Filterline, Microstream Advance Neonatal-Infant Nasal Filter Line With O2 Tubing/Microstream, Microstream EtCO2 Consumables, Microstream EtCO2 Sampling Smart CapnoLine GuardianTM and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Exporter to the US | accessdata.fda.gov |
| Catheter, Peripheral, Atherectomy | MCW | 2 | Exporter to the US | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Contract manufacturer | accessdata.fda.gov |
| Cuff, Tracheal Tube, Inflatable | BSK | 2 | Exporter to the US | accessdata.fda.gov |
| Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | PAY | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 15, 2023 | K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| June 9, 2023 | K230709 | Auryon Atherectomy System | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| September 26, 2022 | K220116 | Auryon Atherectomy Catheters | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| June 9, 2022 | K221077 | Auryon Atherectomy System | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| March 22, 2019 | K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| February 8, 2019 | K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| December 18, 2015 | DEN150005 | Newa Skin Therapy System | PAY | Unknown | Endymed Medical, Ltd. | accessdata.fda.gov |
| May 3, 2013 | K122721 | AG GUFFILL | BSK | Substantially Equivalent | Hospitech Respiration , Ltd. | accessdata.fda.gov |
| March 4, 2010 | K093388 | SMART CAPNOLINE GUARDIAN | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
| November 14, 2001 | K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | CCK | Substantially Equivalent | Oridion Medical 1987 , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- All makers of Catheter, Peripheral, Atherectomy
- All makers of Connector, Airway (Extension)
- All makers of Cuff, Tracheal Tube, Inflatable
- All makers of Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Updated December 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.