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)— 510(k) K211061

Substantially Equivalent

Thrombolex, Inc.

FDA 510(k) clearance K211061 for 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), Substantially Equivalent on 2021-06-10. Applicant: Thrombolex, Inc..

Clearance details

Applicant: Thrombolex, Inc.
Product code: Code QEY
Advisory panel: Cardiovascular
Date received: 2021-04-09
Decision date: 2021-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Britain, PA, US

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