Cleared Traditional

K213422 - EkoSonic Endovascular Device, EKOS+ Endovascular Device (FDA 510(k) Clearance)

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

K213422 · Boston Scientific Corporation · Cardiovascular device
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Dec 2021
Decision
55d
Days
Class 2
Risk

K213422 is an FDA 510(k) clearance for the EkoSonic Endovascular Device, EKOS+ Endovascular Device. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on December 14, 2021 after a review of 55 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K213422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2021
Decision Date December 14, 2021
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 Peers - QEY Mechanical Thrombolysis Catheter

All 70
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K213422.
Versus™ Catheter (VS110-9NB)
K260149 · Liquet Medical, Inc. · Feb 2026
VariFuse Adjustable Infusion Catheter
K251318 · Argon Medical Devices, Inc. · Jan 2026
Versus™ Catheter (VS110-8B)
K241851 · Liquet Medical, Inc. · Nov 2024
EKOS+ Endovascular Device
K220866 · Boston Scientific · Apr 2022
EkoSonic Endovascular Device
K211080 · Boston Scientific · Nov 2021