Cleared Traditional

K120346 - CLEANER ROTATIONAL THROMBECTOMY SYSTEM

K120346 is an FDA 510(k) clearance for CLEANER ROTATIONAL THROMBECTOMY SYSTEM, manufactured by Rex Medical. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K120346 · Rex Medical · Cardiovascular device
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Jun 2012
Decision
119d
Days
Class 2
Risk

K120346 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 (Great Neck, US). The FDA issued a Cleared decision on June 1, 2012 after a review of 119 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K120346

510(k) Number K120346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2012
Decision Date June 01, 2012
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 55
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K120346.
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