FDA.reportPublic FDA data

510(k) K200648

Device
EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
Applicant
Ekos Corporation
510(k) number
K200648
Product code
QEY
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-17
Date received
2020-03-12
Regulation
870.5150
Classification name
Mechanical Thrombolysis Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joshua Kim
Address
11911 N. Creek Pkwy. S. Bothell WA US 98011 98011

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QEY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.2024-11-25
K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.2023-07-03
K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.2023-04-20
K220866EKOS+ Endovascular DeviceBoston Scientific2022-04-20
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K211080EkoSonic Endovascular DeviceBoston Scientific2021-11-19
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K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.2020-09-15
K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.2020-06-01
K193071Bashir Plus Endovascular CatheterThrombolex, Inc.2019-12-17
K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.2019-10-18
K191119EkoSonic Endovascular DeviceBtg International, Inc.2019-08-23
K183361EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc.2019-04-05