Cleared Special

K071042 - POLARCATH PERIPHERAL DILATATION SYSTEM

K071042 is the FDA 510(k) clearance for POLARCATH PERIPHERAL DILATATION SYSTEM by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 62-day FDA review.

K071042 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
62d
Days
Class 2
Risk

K071042 is an FDA 510(k) clearance for the POLARCATH PERIPHERAL DILATATION SYSTEM. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on June 13, 2007 after a review of 62 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 Boston Scientific Corp devices

Submission Details

510(k) Number K071042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2007
Decision Date June 13, 2007
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
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 238
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K071042.
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K060960 · Boston Scientific Corporation · Apr 2006