Cleared Special

K101406 - ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001

K101406 is an FDA 510(k) clearance for ANGIOJET SOLENT PROXI THROMBECTOMY SET ..., manufactured by Medrad Interventional/Possis. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Special 510(k) pathway after a 28-day FDA review.

K101406 · Medrad Interventional/Possis · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
28d
Days
Class 2
Risk

K101406 is an FDA 510(k) clearance for the ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Medrad Interventional/Possis (Minneapolis, US). The FDA issued a Cleared decision on June 16, 2010 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.

FDA 510(k) Submission Details - K101406

510(k) Number K101406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2010
Decision Date June 16, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
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.

QEZ Device Classification - Class 2, Special Controls

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary 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 - QEZ Aspiration Thrombectomy Catheter

All 94
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K101406.
FETCH 2 ASPIRATION CATHETER MODEL 109400-001
K101354 · Medrad Interventional/Possis · Jan 2011
PRONTO V4 EXTRACTION CATHETER 5.5F
K103405 · Vascular Solutions, Inc. · Dec 2010
KANEKA PHARMA AMERICA XPRESS-WAY RX
K101839 · Kaneka Pharma America, LLC · Oct 2010
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
K091703 · Concentric Medical, Inc. · Oct 2009
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
K091593 · Possis Medical, Inc. · Jun 2009
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
K090253 · Possis Medical, Inc. · Apr 2009
K101406 · ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001
Download PDF FDA Summary Medrad Interventional…