Cleared Special

CORDIS AMIIA .014 PTA BALLOON CATHETER (K050645) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050645 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
18d
Days
Class 2
Risk

K050645 is an FDA 510(k) clearance for the CORDIS AMIIA .014 PTA BALLOON CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on April 1, 2005 after a review of 18 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 Corp. devices

Submission Details

510(k) Number K050645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2005
Decision Date April 01, 2005
Days to Decision 18 days
Submission Type Special
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
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 167
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K050645.
SYMMETRY BALLOON DILATATION CATHETER
K060959 · Boston Scientific Corporation · Apr 2006
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
K060960 · Boston Scientific Corporation · Apr 2006
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
K052038 · Boston Scientific Corporation · Aug 2005
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · Cook, Inc. · Nov 2002
CORDIS SLALOM PTA BALLOON CATHETER
K003159 · Cordis Corp. · Oct 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · Boston Scientific Corp · Aug 2000