Cleared Traditional

K101354 - FETCH 2 ASPIRATION CATHETER MODEL 109400-001

K101354 is an FDA 510(k) clearance for FETCH 2 ASPIRATION CATHETER MODEL 10940..., manufactured by Medrad Interventional/Possis. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K101354 · Medrad Interventional/Possis · Cardiovascular device
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Jan 2011
Decision
252d
Days
Class 2
Risk

K101354 is an FDA 510(k) clearance for the FETCH 2 ASPIRATION CATHETER MODEL 109400-001. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Medrad Interventional/Possis (Minneapolis, US). The FDA issued a Cleared decision on January 21, 2011 after a review of 252 days - an extended review cycle.

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 Medrad Interventional/Possis devices

FDA 510(k) Submission Details - K101354

510(k) Number K101354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2010
Decision Date January 21, 2011
Days to Decision 252 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 125d · This submission: 252d
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 74
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K101354.
XL EXTRACTION CATHETER
K112571 · Vascular Solutions, Inc. · Oct 2011
ANGIOJET SOLENT OMNI THROMBECTOMY SET
K111182 · Medrad, Inc. · May 2011
MERIT EMBOLECTOMY CATHETER MODEL ASAP100
K100569 · Merit Medical Systems, Inc. · Mar 2011
PRONTO V4 EXTRACTION CATHETER 5.5F
K103405 · Vascular Solutions, Inc. · Dec 2010
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
K091703 · Concentric Medical, Inc. · Oct 2009
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
K091593 · Possis Medical, Inc. · Jun 2009