Cleared Traditional

Bashir Plus Endovascular Catheter

K193071 · Thrombolex, Inc. · Cardiovascular
Dec 2019
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K193071 is an FDA 510(k) clearance for the Bashir Plus Endovascular Catheter, a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by Thrombolex, Inc. (New Britain, US). The FDA issued a Cleared decision on December 17, 2019, 43 days after receiving the submission on November 4, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K193071 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2019
Decision Date December 17, 2019
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QEY — Mechanical Thrombolysis Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.

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