Cleared Special

K060904 - CLEANER ROTATIONAL THROMBECTOMY SYSTEM

K060904 is an FDA 510(k) clearance for CLEANER ROTATIONAL THROMBECTOMY SYSTEM, manufactured by Rex Medical, L.P.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 25-day FDA review.

K060904 · Rex Medical, L.P. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
25d
Days
Class 2
Risk

K060904 is an FDA 510(k) clearance for the CLEANER ROTATIONAL THROMBECTOMY SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Rex Medical, L.P. (Great Neck, US). The FDA issued a Cleared decision on April 28, 2006 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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 Rex Medical, L.P. devices

FDA 510(k) Submission Details - K060904

510(k) Number K060904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2006
Decision Date April 28, 2006
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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 - MCW Catheter, Peripheral, Atherectomy

All 76
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K060904.
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