Cleared Special

K111182 - ANGIOJET SOLENT OMNI THROMBECTOMY SET

K111182 is the FDA 510(k) clearance for ANGIOJET SOLENT OMNI THROMBECTOMY SET by Medrad, Inc.. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Special 510(k) pathway after a 27-day FDA review.

K111182 · Medrad, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2011
Decision
27d
Days
Class 2
Risk

K111182 is an FDA 510(k) clearance for the ANGIOJET SOLENT OMNI THROMBECTOMY SET. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Medrad, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 24, 2011 after a review of 27 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 Medrad, Inc. devices

Submission Details

510(k) Number K111182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2011
Decision Date May 24, 2011
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 69
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