Cleared Special

K042937 - MODIFICATION TO VASCULAR SOLUTIONS PRON...

K042937 is the FDA 510(k) clearance for MODIFICATION TO VASCULAR SOLUTIONS PRON... by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Special 510(k) pathway after a 98-day FDA review.

K042937 · Vascular Solutions, Inc. · Cardiovascular device
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Jan 2005
Decision
98d
Days
Class 2
Risk

K042937 is an FDA 510(k) clearance for the MODIFICATION TO VASCULAR SOLUTIONS PRONTO 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 January 31, 2005 after a review of 98 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K042937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2004
Decision Date January 31, 2005
Days to Decision 98 days
Submission Type Special
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
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 50
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K042937.
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER
K052232 · Vascular Solutions, Inc. · Sep 2005
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
K051193 · Vascular Solutions, Inc. · Aug 2005
MODIFICATION TO: EXPORT CATHETER
K050139 · Medtronic Vascular · Mar 2005
EXPORT CATHETER
K040869 · Medtronic Vascular · Jun 2004
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K032763 · Vascular Solutions, Inc. · Dec 2003
6F HYDROLYSER THROMBECTOMY CATHETER
K990771 · Cordis Corp. · Jun 1999