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

Mechanical Thrombolysis Catheter

21 CFR 870.5150 / Cardiovascular
FDA source (opens on fda.gov)

QEY is the FDA product code for Mechanical Thrombolysis Catheter, a class II device type, regulated under 21 CFR 870.5150. FDA's definition for this code reads: "To mechanically disrupt thrombus and/or debris in the peripheral vasculature". As of , FDA records hold 71 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
QEY
Device name
Mechanical Thrombolysis Catheter
FDA definition
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
71
Ingested recalls
4

Clearances, product code QEY

By decision year
71 clearances under product code QEY with a decision year between 1995 and 2026, 2005 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code QEY by decision year
YearClearances
19955
19961
19973
19983
19992
20023
20034
20045
20056
20063
20075
20084
20111
20131
20141
20151
20162
20173
20181
20195
20203
20213
20221
20232
20241
20262

Applicants with the most clearances

Product code QEY
Applicants holding the most 510(k) clearances under product code QEY
ApplicantClearances
Ekos Corp.19
Boston Scientific Corporation9
Bacchus Vascular, Inc.7
Thrombolex, Inc.6
Btg International, Inc.5
Merit Medical Systems, Inc.5
Localmed, Inc.4
Omnisonics Medical Technologies4
Angiodynamics, Div. E-Z-Em, Inc.3
Advanced Catheter Therapies, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order