Cleared Special

K080264 - MODIFICATION TO: FOX PLUS PTA CATHETER

K080264 is an FDA 510(k) clearance for MODIFICATION TO: FOX PLUS PTA CATHETER, manufactured by Abbott Vascular-Vascular Solutions. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 54-day FDA review.

K080264 · Abbott Vascular-Vascular Solutions · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
54d
Days
Class 2
Risk

K080264 is an FDA 510(k) clearance for the MODIFICATION TO: FOX PLUS PTA CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Abbott Vascular-Vascular Solutions (Santa Clara, US). The FDA issued a Cleared decision on March 26, 2008 after a review of 54 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 Abbott Vascular-Vascular Solutions devices

FDA 510(k) Submission Details - K080264

510(k) Number K080264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2008
Decision Date March 26, 2008
Days to Decision 54 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
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 352
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K080264.
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
K080982 · Boston Scientific Corp · Jul 2008
FOXCROSS PTA CATHETER
K081417 · Abbott Vascular, Inc. · Jun 2008
FOX PLUS PTA CATHETER
K080925 · Abbott Vascular, Inc. · Apr 2008
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
K072947 · ClearStream Technologies , Ltd. · Feb 2008
VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
K072798 · Abbott Vascular-Vascular Solutions · Jan 2008
VACCESS PTA BALLOON DILATATION CATHETER
K073472 · C.R. Bard, Inc. · Jan 2008