Cleared Traditional

TERUMO ASPRIATION CATHETER (K112382) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112382 · Terumo Medical Corporation · Cardiovascular device
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Dec 2011
Decision
118d
Days
Class 2
Risk

K112382 is an FDA 510(k) clearance for the TERUMO ASPRIATION CATHETER. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on December 14, 2011 after a review of 118 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 Terumo Medical Corporation devices

Submission Details

510(k) Number K112382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2011
Decision Date December 14, 2011
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 35
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K112382.
Merit ASAPLP Aspiration Catheter
K132155 · Merit Medical Systems, Inc. · Nov 2013
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · Medtronic, Inc. · Jul 2013
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · Medtronic, Inc. · Jun 2012
MERIT EMBOLECTOMY CATHETER MODEL ASAP100
K100569 · Merit Medical Systems, Inc. · Mar 2011
FLEXOR EVAC ASPIRATION CATHETER
K073627 · Cook, Inc. · Mar 2008
MEDTRONIC EXPORT XT CATHETER
K061958 · Medtronic Vascular · Sep 2006