Cleared Special

K060572 - MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM

K060572 is an FDA 510(k) clearance for MODIFICATION TO POLARCATH PERIPHERAL DI..., manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 9-day FDA review.

K060572 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
9d
Days
Class 2
Risk

K060572 is an FDA 510(k) clearance for the MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Los Gatos, US). The FDA issued a Cleared decision on March 15, 2006 after a review of 9 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 Corporation devices

FDA 510(k) Submission Details - K060572

510(k) Number K060572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2006
Decision Date March 15, 2006
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
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.

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All 785
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