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Suzhou Zenith Vascular Scitech Limited: FDA-registered device maker in Suzhou Jiangsu, China, 4 510(k) clearances

Name: Suzhou Zenith Vascular Scitech Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Suzhou Zenith Vascular Scitech Limited is registered with the FDA (registration 3039020025) in Suzhou Jiangsu, China. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 22, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3039020025
Address: Ground Floor to 5th Floor, Underground Unit B102, Building 6, Block B, Phase 5, Biobay No.21 Dongyanli Road, SIP, Suzhou Jiangsu, China, 215123
Owner or operator: Suzhou Zenith Vascular SciTech Limited (10095913)
Roles: Manufacturer
First device listed: May 21, 2026
Registered through: 2026
Brand names listed: Micro Catheter, Zenith Aspiration Catheter; Disposable Aspiration Tubing Set, Zenith Distal Access Long Sheath, Zenith Micro Guidewire

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Continuous Flush	KRA	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Manufacturer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Manufacturer	accessdata.fda.gov
Guide, Wire, Catheter, Neurovasculature	MOF	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	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
May 22, 2026	K253359	Zenith Distal Access Long Sheath	QJP	Substantially Equivalent	Suzhou Zenith Vascular SciTech Limited	accessdata.fda.gov
May 20, 2026	K252707	Zenith Aspiration Catheter; Disposable Aspiration Tubing Set	NRY	Substantially Equivalent	Suzhou Zenith Vascular SciTech Limited	accessdata.fda.gov
April 16, 2026	K252317	Zenith Micro Guidewire	MOF	Substantially Equivalent	Suzhou Zenith Vascular SciTech Limited	accessdata.fda.gov
July 30, 2025	K243534	Micro Catheter	KRA	Substantially Equivalent	Suzhou Zenith Vascular SciTech Limited	accessdata.fda.gov

Compare with other makers

Updated May 22, 2026. 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.