BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter— 510(k) K231653

Substantially Equivalent

Thrombolex, Inc.

FDA 510(k) clearance K231653 for BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter, Substantially Equivalent on 2023-07-03. Applicant: Thrombolex, Inc..

Clearance details

Applicant: Thrombolex, Inc.
Product code: Code QEY
Advisory panel: Cardiovascular
Date received: 2023-06-06
Decision date: 2023-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: New Britain, PA, US

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