Cleared Special

K062594 - MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM

K062594 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 19-day FDA review.

K062594 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
19d
Days
Class 2
Risk

K062594 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 September 20, 2006 after a review of 19 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 - K062594

510(k) Number K062594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2006
Decision Date September 20, 2006
Days to Decision 19 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
106d faster than avg
Panel avg: 125d · This submission: 19d
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.

Regulatory Peers - DQY Catheter, Percutaneous

All 895
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K062594 · MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
Download PDF FDA Summary Boston Scientific Cor…