Cleared Traditional

K091029 - CLEANER ROTATIONAL THROMBECTOMY SYSTEM ...

K091029 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 314-day FDA review.

K091029 · Rex Medical · Cardiovascular device
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Feb 2010
Decision
314d
Days
Class 2
Risk

K091029 is an FDA 510(k) clearance for the CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM). 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 February 18, 2010 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K091029

510(k) Number K091029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2009
Decision Date February 18, 2010
Days to Decision 314 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
189d slower than avg
Panel avg: 125d · This submission: 314d
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 K091029.
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
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TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · Ev3, Inc. · Jan 2011
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K093301 · Ev3, Inc. · Nov 2009
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
K993564 · Possis Medical, Inc. · Apr 2000
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
K990829 · Arrow Intl., Inc. · May 1999