Cleared Traditional

K052232 - VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER

K052232 is an FDA 510(k) clearance for VASCULAR SOLUTIONS PRONTO V3 EXTRACTION..., manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K052232 · Vascular Solutions, Inc. · Cardiovascular device
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Sep 2005
Decision
42d
Days
Class 2
Risk

K052232 is an FDA 510(k) clearance for the VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 28, 2005 after a review of 42 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 Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K052232

510(k) Number K052232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2005
Decision Date September 28, 2005
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
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 81
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K052232.
QUICKCAT EXTRACTION CATHETER
K060092 · Kensey Nash Corp. · Mar 2006
RIO ASPIRATION CATHETER
K051880 · Boston Scientific Corp · Jan 2006
ANGIOJET XPEEDIOR 120 CATHETER
K052256 · Possis Medical, Inc. · Nov 2005
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
K051193 · Vascular Solutions, Inc. · Aug 2005
ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
K050794 · Possis Medical, Inc. · Apr 2005
MODIFICATION TO: EXPORT CATHETER
K050139 · Medtronic Vascular · Mar 2005