510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K202218Substantially Equivalent

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device

Boston Scientific Corporation, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202218 is the FDA 510(k) clearance record for ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device, a class II device, cleared for Boston Scientific Corporation on under FDA product code QEW (Peripheral Mechanical Thrombectomy With Aspiration). FDA's definition for product code QEW reads: "To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration". FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K202218.

Clearance record

Decision date
Received
(57 days to decision)
Product code
QEW Peripheral Mechanical Thrombectomy With Aspiration
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corporation 3 Scimed Pl., Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEW

Trailing 12 months
11 clearances under product code QEW in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QEW, trailing twelve months
MonthClearances
November 20251
December 20251
January 20262
February 20262
March 20260
April 20261
May 20260
June 20260
July 20260
August 20262
September 20262
October 20260