Data / Medical devices / China / Lifetech Scientific (shenzhen) Co,.ltd
Lifetech Scientific (shenzhen) Co,.ltd: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Lifetech Scientific (shenzhen) Co,.ltd is registered with the FDA (registration 3008423561) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 24, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008423561
- Address
- 8F, LifeTech Scientific Building, No.22, Keji 12th Road South High-tech Industrial Park, Yuehai Subdistrict, Nanshan District, Shenzhen Guangdong, China, 518063
- Owner or operator
- Lifetech Scientific (Shenzhen) Co,.Ltd (10036342)
- Roles
- Manufacturer
- First device listed
- May 3, 2011
- Registered through
- 2026
- Brand names listed
- FuStar, LawMax Dilator, SeQure
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Device, Percutaneous Retrieval | MMX | 2 | Manufacturer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 24, 2013 | K123842 | LAWMAX DILATOR | DRE | Substantially Equivalent | Lifetech Scientific (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| February 14, 2011 | K100184 | FUSTAR STEERABLE INTRODUCERS | DQY | Substantially Equivalent | Lifetech Scientific (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| November 9, 2010 | K102484 | SEQURE SNARE SYSTEM | MMX | Substantially Equivalent | Lifetech Scientific (Shenzhen) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Vessel, For Percutaneous Catheterization
- All makers of Device, Percutaneous Retrieval
- All makers of Catheter, Percutaneous
Updated June 24, 2013. 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.