Cleared Traditional

K051193 - VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER

K051193 is an FDA 510(k) clearance for VASCULAR SOLUTIONS PRONTO SHORT EXTRACT..., 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 90-day FDA review.

K051193 · Vascular Solutions, Inc. · Cardiovascular device
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Aug 2005
Decision
90d
Days
Class 2
Risk

K051193 is an FDA 510(k) clearance for the VASCULAR SOLUTIONS PRONTO SHORT 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 August 8, 2005 after a review of 90 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 Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K051193

510(k) Number K051193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2005
Decision Date August 08, 2005
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K051193.
RIO ASPIRATION CATHETER
K051880 · Boston Scientific Corp · Jan 2006
ANGIOJET XPEEDIOR 120 CATHETER
K052256 · Possis Medical, Inc. · Nov 2005
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER
K052232 · Vascular Solutions, Inc. · Sep 2005
ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
K050794 · Possis Medical, Inc. · Apr 2005
MODIFICATION TO: EXPORT CATHETER
K050139 · Medtronic Vascular · Mar 2005
MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K042937 · Vascular Solutions, Inc. · Jan 2005