Cleared Special

K103405 - PRONTO V4 EXTRACTION CATHETER 5.5F

Also marketed or referenced as:
PRONTO V4 EXTRACTION CATHETER 6F PRONTO V4 EXTRACTION 7F PRONTO V4 EXTRACTION CATH

K103405 is an FDA 510(k) clearance for PRONTO V4 EXTRACTION CATHETER 5.5F, 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 33-day FDA review.

K103405 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
33d
Days
Class 2
Risk

K103405 is an FDA 510(k) clearance for the PRONTO V4 EXTRACTION CATHETER 5.5F. 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 December 22, 2010 after a review of 33 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. 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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K103405

510(k) Number K103405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2010
Decision Date December 22, 2010
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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 81
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K103405.
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K091593 · Possis Medical, Inc. · Jun 2009
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K090253 · Possis Medical, Inc. · Apr 2009