Cleared Traditional

K112382 - TERUMO ASPRIATION CATHETER

K112382 is an FDA 510(k) clearance for TERUMO ASPRIATION CATHETER, manufactured by Terumo Medical Corporation. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

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

FDA 510(k) Submission Details - K112382

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.

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 70
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K112382.
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K111182 · Medrad, Inc. · May 2011