Thrombolex, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterJuly 3, 2023
K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101April 20, 2023
K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR PJune 10, 2021
K193071Bashir Plus Endovascular CatheterDecember 17, 2019
K192598Bashir S-B Endovascular Catheter, Ref. No. 7101October 18, 2019
K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200February 25, 2019