Cleared Traditional

K033793 - CLEANER II ROTATIONAL THROMBECTOMY SYSTEM

K033793 is an FDA 510(k) clearance for CLEANER II 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 11-day FDA review.

K033793 · Rex Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
11d
Days
Class 2
Risk

K033793 is an FDA 510(k) clearance for the CLEANER II 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 December 16, 2003 after a review of 11 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rex Medical devices

FDA 510(k) Submission Details - K033793

510(k) Number K033793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2003
Decision Date December 16, 2003
Days to Decision 11 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
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K033793.
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