510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253359Substantially Equivalent

Zenith Distal Access Long Sheath

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

K253359 is the FDA 510(k) clearance record for Zenith Distal Access Long Sheath, a class II device, cleared for Suzhou Zenith Vascular SciTech Limited on under FDA product code QJP (Catheter, Percutaneous, Neurovasculature). FDA's definition for product code QJP reads: "To provide vascular access to the neurovasculature for interventional or diagnostic procedures". FDA records list 4 510(k) clearances for Suzhou Zenith Vascular SciTech Limited, from to . As of , FDA records show no recalls naming K253359.

Clearance record

Decision date
Received
(234 days to decision)
Product code
QJP Catheter, Percutaneous, Neurovasculature
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Suzhou Zenith Vascular SciTech Limited Unit 101, Bldg. 6, Block B, Phase 5, Biobay, Suzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJP

Trailing 12 months
20 clearances under product code QJP in the twelve months to October 2026, April 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code QJP, trailing twelve months
MonthClearances
November 20250
December 20251
January 20263
February 20261
March 20260
April 20264
May 20262
June 20262
July 20263
August 20262
September 20262
October 20260