Cleared Traditional

K030742 - POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM

K030742 is an FDA 510(k) clearance for POLARCATH PERIPHERAL BALLOON CATHETER S..., manufactured by Cryo Vascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K030742 · Cryo Vascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
172d
Days
Class 2
Risk

K030742 is an FDA 510(k) clearance for the POLARCATH PERIPHERAL BALLOON CATHETER 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 29, 2003 after a review of 172 days - an extended review cycle.

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 Cryo Vascular Systems, Inc. devices

FDA 510(k) Submission Details - K030742

510(k) Number K030742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2003
Decision Date August 29, 2003
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
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 304
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K030742.
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
CORDIS AMIIA .014 PTA BALLOON CATHETER
K050645 · Cordis Corp. · Apr 2005
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · Cook, Inc. · Nov 2002
NUMED GHOST II PTA CATHETERS
K003972 · NuMED, Inc. · Jan 2001
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
K003276 · NuMED, Inc. · Dec 2000