FDA.reportPublic FDA data

510(k) K213422

Device
EkoSonic Endovascular Device, EKOS+ Endovascular Device
Applicant
Boston Scientific Corporation
510(k) number
K213422
Product code
QEY
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-14
Date received
2021-10-20
Regulation
870.5150
Classification name
Mechanical Thrombolysis Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ambreen Athar
Address
Three Scimed Pl. Maple Grove MN US 55311 55311

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
K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.2026-02-17
K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.2026-01-20
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
K211080EkoSonic Endovascular DeviceBoston Scientific2021-11-19
K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)Thrombolex, Inc.2021-06-10
K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.2020-09-15
K200648EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation2020-08-17
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