Cleared Traditional

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) (K211061) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211061 · Thrombolex, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
62d
Days
Class 2
Risk

K211061 is an FDA 510(k) clearance for the BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Cathete.... Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Thrombolex, Inc. (New Britain, US). The FDA issued a Cleared decision on June 10, 2021 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Thrombolex, Inc. devices

Submission Details

510(k) Number K211061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2021
Decision Date June 10, 2021
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEY Mechanical Thrombolysis Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Eminence Clinical Research, Inc.
Diane Horwitz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QEY Mechanical Thrombolysis Catheter

All 27
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K211061.
EKOS+ Endovascular Device
K220866 · Boston Scientific · Apr 2022
EkoSonic Endovascular Device, EKOS+ Endovascular Device
K213422 · Boston Scientific Corporation · Dec 2021
EkoSonic Endovascular Device
K211080 · Boston Scientific · Nov 2021
UNIFUSE Infusion System with Cooper Wire
K202347 · AngioDynamics, Inc. · Sep 2020
EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
K200648 · Ekos Corporation · Aug 2020
UNI*FUSE Infusion System with Cooper Wire
K192864 · AngioDynamics, Inc. · Jun 2020