Thrombolex, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Thrombolex, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter, BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101, BASHIR 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)
6
Total
6
Cleared
0
Denied
Thrombolex, Inc. has 6 FDA 510(k) cleared medical devices. Based in New Britain, US.
Last cleared in 2023. Active since 2019. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Thrombolex, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Eminence Clinical Research, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Thrombolex, Inc.
6 devices
Cleared
Jul 03, 2023
BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
Cardiovascular
27d
Cleared
CT
Apr 20, 2023
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter,...
Cardiovascular
276d
Cleared
Jun 10, 2021
BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular...
Cardiovascular
62d
Cleared
Dec 17, 2019
Bashir Plus Endovascular Catheter
Cardiovascular
43d
Cleared
Oct 18, 2019
Bashir S-B Endovascular Catheter, Ref. No. 7101
Cardiovascular
28d
Cleared
Feb 25, 2019
Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter,...
Cardiovascular
91d