510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K953384Substantially Equivalent

Multi Side Hole lnfusion System

Boston Scientific Corporation, Glens Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953384 is the FDA 510(k) clearance record for Multi Side Hole lnfusion System, a class II device, cleared for AngioDynamics, Inc. on under FDA product code QEY (Mechanical Thrombolysis Catheter). FDA's definition for product code QEY reads: "To mechanically disrupt thrombus and/or debris in the peripheral vasculature". FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K953384.

Clearance record

Decision date
Received
(156 days to decision)
Product code
QEY Mechanical Thrombolysis Catheter
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
AngioDynamics, Inc. P.O. Box 993, Glens Falls NY
510(k) summary
Statement
Third party review
No

Clearances, product code QEY

Trailing 12 months
2 clearances under product code QEY in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QEY, trailing twelve months
MonthClearances
December 20250
January 20261
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260