Clearance Summary
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) received FDA 510(k) clearance under submission number K211061, sponsored by Thrombolex, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-06-10.
- Submission: K211061
- Applicant / Sponsor: Thrombolex, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2021-06-10
Classification & Regulation
This clearance is catalogued under FDA product code QEY and 21 CFR 870.5150, within the Cardiovascular review panel as a Class II device.