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

Aspiration Thrombectomy Catheter

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

QEZ is the FDA product code for Aspiration Thrombectomy Catheter, a class II device type, regulated under 21 CFR 870.5150. FDA's definition for this code reads: "To remove thrombus from the peripheral and/or coronary vasculature through aspiration". As of , FDA records hold 94 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QEZ
Device name
Aspiration Thrombectomy Catheter
FDA definition
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
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
Yes
Third party review eligible
No
Ingested clearances
95
Ingested recalls
0

Clearances, product code QEZ

By decision year
95 clearances under product code QEZ with a decision year between 1999 and 2026, 2007 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code QEZ by decision year
YearClearances
19993
20001
20031
20043
20059
20068
200711
20086
20094
20103
20117
20125
20134
20141
20161
20173
20181
20193
20203
20213
20222
20231
20241
20255
20266

Applicants with the most clearances

Product code QEZ
Applicants holding the most 510(k) clearances under product code QEZ
ApplicantClearances
Possis Medical, Inc.19
Vascular Solutions LLC13
Walk Vascular, LLC9
Medtronic, Inc.6
Boston Scientific Corporation5
Control Medical Technology3
Cordis US Corp.3
Inquis Medical, Inc.3
Medrad, Inc.3
Merit Medical Systems, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order