Cleared Traditional

K151313 - ZelanteDVT Thrombectomy Set

K151313 is an FDA 510(k) clearance for ZelanteDVT Thrombectomy Set, manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K151313 · Boston Scientific Corporation · Cardiovascular device
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Sep 2015
Decision
126d
Days
Class 2
Risk

K151313 is an FDA 510(k) clearance for the ZelanteDVT Thrombectomy Set. 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 September 21, 2015 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corporation devices

FDA 510(k) Submission Details - K151313

510(k) Number K151313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date September 21, 2015
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEW Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K151313.
Penumbra Aspiration System
K161506 · Penumbra, Inc. · Sep 2016
INDIGO Aspiration System
K161523 · Penumbra, Inc. · Jul 2016
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
K160533 · Penumbra, Inc. · May 2016
Retraction Aspirator
K152097 · Inari Medical · Aug 2015
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
K142870 · Penumbra, Inc. · May 2015
Infusion Aspiration Catheter System
K143563 · Inari Medical, Inc. · Feb 2015