FDA.reportPublic FDA data

510(k) K231653

Device
BASHIR? .035 Endovascular Catheter, BASHIR? S-B .035 Endovascular Catheter
Applicant
Thrombolex, Inc.
510(k) number
K231653
Product code
QEY
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-03
Date received
2023-06-06
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
Amy Katsikas
Address
75 New Britain Dr. New Britain PA US 18901 18901

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
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
K183361EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc.2019-04-05