Cleared Traditional

K072798 - VIATRAC 14 PLUS PERIPHERAL DILATION CAT...

K072798 is the FDA 510(k) clearance for VIATRAC 14 PLUS PERIPHERAL DILATION CAT... by Abbott Vascular-Vascular Solutions. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K072798 · Abbott Vascular-Vascular Solutions · Cardiovascular device
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Jan 2008
Decision
122d
Days
Class 2
Risk

K072798 is an FDA 510(k) clearance for the VIATRAC 14 PLUS PERIPHERAL DILATION 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 January 31, 2008 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Vascular-Vascular Solutions devices

Submission Details

510(k) Number K072798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2007
Decision Date January 31, 2008
Days to Decision 122 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 240
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