Cleared Special

K050645 - CORDIS AMIIA .014 PTA BALLOON CATHETER

K050645 is an FDA 510(k) clearance for CORDIS AMIIA .014 PTA BALLOON CATHETER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 18-day FDA review.

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

FDA 510(k) Submission Details - K050645

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.

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 369
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K050645.
METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000
K051042 · Angiometrx, Inc. · Aug 2005
POLAR CATH PERIPHERAL DILATATION SYSTEM
K051916 · Cryo Vascular Systems, Inc. · Aug 2005
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
K051519 · Abbott Laboratories (Perclose, Inc.) · Jun 2005
BIOPORE BALLOON DILATION CATHETER
K041293 · Bipore, Inc. · Jul 2004
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0
K030062 · Avantec Vascular Corp. · Apr 2003
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · Cook, Inc. · Nov 2002