ClearanceBrief
Panels › Cardiovascular › Product code QEY · Class 2

Mechanical Thrombolysis Catheter

Regulation 870.5150

2510(k)s in 12 months (71 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in QEY

Company510(k)sRecalls
Ekos Corp.190
Bacchus Vascular, Inc.70
AngioDynamics, Inc.60
Boston Scientific33
Merit Medical Systems, Inc.51
Thrombolex, Inc.60
Btg International, Inc.50
Localmed, Inc.40
Omnisonics Medical Technologies40
Angiodynamics, Div. E-Z-Em, Inc.30
DateFirm and productCodeLinked 510(k)
Jan 2, 2024Merit Medical Systems, Inc.
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Open, Classified		 QEYK992231
Oct 28, 2022Boston Scientific Corporation
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Open, Classified		 QEYK162771
K183361 +1
May 25, 2022Boston Scientific Corporation
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch.
Open, Classified		 QEYK213422
May 25, 2022Boston Scientific Corporation
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch.
Open, Classified		 QEYK213422

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