Cleared Traditional

K063563 - CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ...

K063563 is an FDA 510(k) clearance for CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ..., manufactured by Cordis Europa, N.V.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K063563 · Cordis Europa, N.V. · Cardiovascular device
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Mar 2007
Decision
99d
Days
Class 2
Risk

K063563 is an FDA 510(k) clearance for the CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION C.... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Europa, N.V. (Warren, US). The FDA issued a Cleared decision on March 7, 2007 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Cordis Europa, N.V. devices

FDA 510(k) Submission Details - K063563

510(k) Number K063563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2006
Decision Date March 07, 2007
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 262
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K063563.
FOX SV PTA CATHETER
K072824 · Abbott Laboratories · Oct 2007
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K071309 · Boston Scientific Corp · Jul 2007
POLARCATH PERIPHERAL DILATATION SYSTEM
K071042 · Boston Scientific Corp · Jun 2007
FOX SV PTA CATHETER
K062843 · Abbott Laboratories · Oct 2006
SYMMETRY BALLOON DILATATION CATHETER
K060959 · Boston Scientific Corporation · Apr 2006
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
K060960 · Boston Scientific Corporation · Apr 2006