Cleared Traditional

K061951 - ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120

K061951 is an FDA 510(k) clearance for ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOM..., manufactured by Possis Medical, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K061951 · Possis Medical, Inc. · Cardiovascular device
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Nov 2006
Decision
135d
Days
Class 2
Risk

K061951 is an FDA 510(k) clearance for the ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Possis Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 22, 2006 after a review of 135 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 Possis Medical, Inc. devices

FDA 510(k) Submission Details - K061951

510(k) Number K061951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2006
Decision Date November 22, 2006
Days to Decision 135 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
10d slower than avg
Panel avg: 125d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 88
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K061951.
PRONTO .035 EXTRACTION CATHETER
K070403 · Vascular Solutions, Inc. · Jun 2007
FETCH ASPIRATION CATHETER
K070363 · Possis Medical, Inc. · May 2007
PRONTO V3 EXTRACTION CATHETER, MODEL 5003
K063371 · Vascular Solutions, Inc. · Dec 2006
FETCH ASPIRATION CATHETER
K062172 · Possis Medical, Inc. · Sep 2006
RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
K062275 · Kerberos Proximal Solutions, Inc. · Sep 2006
MEDTRONIC EXPORT XT CATHETER
K061958 · Medtronic Vascular · Sep 2006