510(k) K042456

Device
Lysus Infusion System
Applicant
Ekos Corp.
510(k) number
K042456
Product code
QEY
Decision
Substantially Equivalent (SESE)
Decision date
2004-09-23
Date received
2004-09-10
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
N

Applicant Contact#

Contact
JOCELYN KERSTEN
Address
22030 20th Ave. SE Suite 101 Bothell WA US 98021 98021

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
K213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation2021-12-14
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