Cleared Traditional

K083784 - PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,

K083784 is an FDA 510(k) clearance for PRONTO V3 EXTRACTION CENTER, 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 101-day FDA review.

K083784 · Vascular Solutions, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2009
Decision
101d
Days
Class 2
Risk

K083784 is an FDA 510(k) clearance for the PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL.... 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 March 30, 2009 after a review of 101 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 - K083784

510(k) Number K083784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2008
Decision Date March 30, 2009
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
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 K083784.
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
K091703 · Concentric Medical, Inc. · Oct 2009
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ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
K090253 · Possis Medical, Inc. · Apr 2009
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K082382 · Possis Medical, Inc. · Dec 2008
MODIFICATION TO FETCH ASPIRATION CATHETER
K081989 · Possis Medical, Inc. · Sep 2008
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
K080806 · Possis Medical, Inc. · Apr 2008