Cleared Special

K083335 - MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM

K083335 is an FDA 510(k) clearance for MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM, manufactured by Omnisonics Medical Technologies. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Special 510(k) pathway after a 33-day FDA review.

K083335 · Omnisonics Medical Technologies · Cardiovascular device
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Dec 2008
Decision
33d
Days
Class 2
Risk

K083335 is an FDA 510(k) clearance for the MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Omnisonics Medical Technologies (Wilmington, US). The FDA issued a Cleared decision on December 15, 2008 after a review of 33 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 Omnisonics Medical Technologies devices

FDA 510(k) Submission Details - K083335

510(k) Number K083335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date December 15, 2008
Days to Decision 33 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 125d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

QEY Device Classification - Class 2, Special Controls

Product Code QEY Mechanical Thrombolysis Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.
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 - QEY Mechanical Thrombolysis Catheter

All 30
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K083335.
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