Cleared Special

K071189 - CORDIS AVIATOR PLUS PTA BALLOON DILATAT...

K071189 is an FDA 510(k) clearance for CORDIS AVIATOR PLUS PTA BALLOON DILATAT..., manufactured by Cordis Europa, N.V.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 16-day FDA review.

K071189 · Cordis Europa, N.V. · Cardiovascular device
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May 2007
Decision
16d
Days
Class 2
Risk

K071189 is an FDA 510(k) clearance for the CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Europa, N.V. (Roden, Drenthe, NL). The FDA issued a Cleared decision on May 16, 2007 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cordis Europa, N.V. devices

FDA 510(k) Submission Details - K071189

510(k) Number K071189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date May 16, 2007
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K071189.
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K071309 · Boston Scientific Corp · Jul 2007
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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