Cleared Traditional

K021096 - X-SIZER CATHETER SYSTEM

K021096 is an FDA 510(k) clearance for X-SIZER CATHETER SYSTEM, manufactured by Ev3 Corporation. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 888-day FDA review.

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

FDA 510(k) Submission Details - K021096

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
Combination Product No
PCCP Authorized No
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.

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 129
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K021096.
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