Cleared Special

K051916 - POLAR CATH PERIPHERAL DILATATION SYSTEM

K051916 is an FDA 510(k) clearance for POLAR CATH PERIPHERAL DILATATION SYSTEM, manufactured by Cryo Vascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 21-day FDA review.

K051916 · Cryo Vascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
21d
Days
Class 2
Risk

K051916 is an FDA 510(k) clearance for the POLAR CATH PERIPHERAL DILATATION SYSTEM. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cryo Vascular Systems, Inc. (Los Gatos, US). The FDA issued a Cleared decision on August 5, 2005 after a review of 21 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.

FDA 510(k) Submission Details - K051916

510(k) Number K051916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2005
Decision Date August 05, 2005
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 402
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K051916.
PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K052757 · Biotronik AG · Oct 2005
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
K052038 · Boston Scientific Corporation · Aug 2005
METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000
K051042 · Angiometrx, Inc. · Aug 2005
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
K051519 · Abbott Laboratories (Perclose, Inc.) · Jun 2005
CORDIS AMIIA .014 PTA BALLOON CATHETER
K050645 · Cordis Corp. · Apr 2005
BIOPORE BALLOON DILATION CATHETER
K041293 · Bipore, Inc. · Jul 2004
K051916 · POLAR CATH PERIPHERAL DILATATION SYSTEM
Download PDF FDA Summary Cryo Vascular Systems…