Bashir Plus Endovascular Catheter— 510(k) K193071

Substantially Equivalent

Thrombolex, Inc.

FDA 510(k) clearance K193071 for Bashir Plus Endovascular Catheter, Substantially Equivalent on 2019-12-17. Applicant: Thrombolex, Inc..

Clearance details

Applicant: Thrombolex, Inc.
Product code: Code QEY
Advisory panel: Cardiovascular
Date received: 2019-11-04
Decision date: 2019-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Britain, PA, US

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