Cleared Traditional

X-SIZER CATHETER SYSTEM (K021096) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021096 · Ev3 Corporation · Cardiovascular device
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Sep 2004
Decision
888d
Days
Class 2
Risk

K021096 is an FDA 510(k) clearance for the X-SIZER CATHETER SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Ev3 Corporation (Plymouth, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 888 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Ev3 Corporation devices

Submission Details

510(k) Number K021096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2002
Decision Date September 08, 2004
Days to Decision 888 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
763d slower than avg
Panel avg: 125d · This submission: 888d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 145
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K021096.
Auryon Atherectomy System
K260244 · Eximo Medical · Apr 2026
FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
K250723 · Cardio Flow Inc., · Apr 2025
Turbo-Elite Laser Atherectomy Catheter
K250385 · Spectranetics · Mar 2025
Rotarex Atherectomy System
K242757 · Bard Peripheral Vascular, Inc. · Jan 2025
FreedomFlow™ Orbital Circumferential Atherectomy System
K242947 · Cardio Flow Inc., · Nov 2024
Auryon Atherectomy Catheter 1.7mm
K241553 · Eximo Medical, Ltd. · Jun 2024