Cleared Traditional

K202218 - ZelanteDVT THrombectomy System

K202218 is the FDA 510(k) clearance for ZelanteDVT THrombectomy System by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code QEW) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K202218 · Boston Scientific Corporation · Cardiovascular device
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Oct 2020
Decision
57d
Days
Class 2
Risk

K202218 is an FDA 510(k) clearance for the ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on October 2, 2020 after a review of 57 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 K202218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2020
Decision Date October 02, 2020
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.
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 - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 126
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K202218.
Triever20 Curve Catheter
K203333 · Inari Medical, Inc. · Dec 2020
FlowTriever Retrieval/Aspiration System
K201541 · Inari Medical · Dec 2020
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
K202821 · Penumbra, Inc. · Nov 2020
Pounce Thrombus Retrieval System
K192814 · Surmodics,Inc. · Sep 2020
ClotTriever Thrombectomy System
K193462 · Inari Medical · Sep 2020
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
K193595 · Penumbra, Inc. · Aug 2020