Cleared Special

K042937 - MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER

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

K042937 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K042937

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.

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 95
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K042937.
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MODIFICATION TO: EXPORT CATHETER
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K050276 · Invatec Innovative Technologies, S.R.L. · Mar 2005
ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
K042874 · Possis Medical, Inc. · Nov 2004
EXPORT CATHETER
K040869 · Medtronic Vascular · Jun 2004
ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT
K040013 · Possis Medical, Inc. · May 2004
K042937 · MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
Download PDF FDA Summary Vascular Solutions, I…