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
SUBSCRIBE / SIGN IN
QEXClass II

Coronary Mechanical Thrombectomy With Aspiration

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

QEX is the FDA product code for Coronary Mechanical Thrombectomy With Aspiration, 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 prior to removal from the coronary vasculature through aspiration". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QEX
Device name
Coronary Mechanical Thrombectomy With Aspiration
FDA definition
To mechanically disrupt thrombus and/or debris prior to removal from the 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
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QEX

By decision year
3 clearances under product code QEX with a decision year between 2017 and 2025, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QEX by decision year
YearClearances
20172
20251

Applicants with the most clearances

Product code QEX
Applicants holding the most 510(k) clearances under product code QEX
ApplicantClearances
Capture Vascular, Inc.1
Penumbra Inc.1
Vesalio1

Companies listing this code with FDA

Companies whose registered establishments list this code