Cleared Traditional

K103260 - VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE

K103260 is an FDA 510(k) clearance for VASCULAR POSITIONING SYSTEM (VPS SYSTEM..., manufactured by Vasonova, Inc.. The device is a Class 2 Cardiovascular device with product code OBJ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K103260 · Vasonova, Inc. · Cardiovascular device
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Feb 2011
Decision
106d
Days
Class 2
Risk

K103260 is an FDA 510(k) clearance for the VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Vasonova, Inc. (Menlo Park, US). The FDA issued a Cleared decision on February 18, 2011 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Vasonova, Inc. devices

FDA 510(k) Submission Details - K103260

510(k) Number K103260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2010
Decision Date February 18, 2011
Days to Decision 106 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
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OBJ Device Classification - Class 2, Special Controls

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OBJ Catheter, Ultrasound, Intravascular

All 63
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