Cleared Special

K093286 - POWERCROSS .018 OTW PTA DILATION CATHETER

K093286 is an FDA 510(k) clearance for POWERCROSS .018 OTW PTA DILATION CATHETER, manufactured by Ev3, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 24-day FDA review.

K093286 · Ev3, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
24d
Days
Class 2
Risk

K093286 is an FDA 510(k) clearance for the POWERCROSS .018 OTW PTA DILATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Ev3, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 13, 2009 after a review of 24 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 - K093286

510(k) Number K093286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2009
Decision Date November 13, 2009
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
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 404
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Download PDF FDA Summary Ev3, Inc.