Cleared Special

K083370 - D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006

K083370 is an FDA 510(k) clearance for D-CLOT THROMBECTOMY CATHETER SYSTEM, manufactured by Artegraft, Inc.. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Special 510(k) pathway after a 28-day FDA review.

K083370 · Artegraft, Inc. · Cardiovascular device
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Dec 2008
Decision
28d
Days
Class 2
Risk

K083370 is an FDA 510(k) clearance for the D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Artegraft, Inc. (North Brunswick, US). The FDA issued a Cleared decision on December 12, 2008 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Artegraft, Inc. devices

FDA 510(k) Submission Details - K083370

510(k) Number K083370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2008
Decision Date December 12, 2008
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 135
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K083370.
ReVive PV (Peripheral Vasculature) Thrombectomy Device
K132281 · Codman & Shurtleff, Inc. · Aug 2013
ANGIOJET ULTRA POWER PULSE KIT
K130381 · Medrad, Inc. · Jul 2013
PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
K121917 · Penumbra, Inc. · Sep 2012
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
K011056 · Arrow Intl., Inc. · Oct 2001
MSD EMBOLECTOMY BASKET
K991093 · Metamorphic Surgical Devices, LLC · Dec 2000