510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K254035Substantially Equivalent

Mayumi™ Thrombectomy System

MicroVention, Inc., d/b/a Terumo Neuro, Aliso Viejo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(261 days to decision)
Product code
QEZ Aspiration Thrombectomy Catheter
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
MicroVention, Inc., d/b/a Terumo Neuro 35 Enterprise, Aliso Viejo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEZ

Trailing 12 months
7 clearances under product code QEZ in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QEZ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20262
August 20260
September 20261
October 20260