510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252317Substantially Equivalent

Zenith Micro Guidewire

Suzhou Zenith Vascular Scitech Limited, Suzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252317 is the FDA 510(k) clearance record for Zenith Micro Guidewire, a class II device, cleared for Suzhou Zenith Vascular SciTech Limited on under FDA product code MOF (Guide, Wire, Catheter, Neurovasculature). FDA records list 4 510(k) clearances for Suzhou Zenith Vascular SciTech Limited, from to . As of , FDA records show no recalls naming K252317.

Clearance record

Decision date
Received
(265 days to decision)
Product code
MOF Guide, Wire, Catheter, Neurovasculature
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Suzhou Zenith Vascular SciTech Limited Bldg. 6, Block B, Phase 5, Biobay, Suzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOF

Trailing 12 months
12 clearances under product code MOF in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20262
April 20262
May 20260
June 20260
July 20261
August 20263
September 20261
October 20260