Cleared Traditional

K944764 - VTI DISPOSABLE PRESSURE DISPLAY SET (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K944764 · Vascular Technology Incorporated · Cardiovascular device
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Dec 1994
Decision
91d
Days
Class 2
Risk

K944764 is an FDA 510(k) clearance for the VTI DISPOSABLE PRESSURE DISPLAY SET. Classified as Gauge, Pressure, Coronary, Cardiopulmonary Bypass (product code DXS), Class II - Special Controls.

Submitted by Vascular Technology Incorporated (Chelmsford, US). The FDA issued a Cleared decision on December 27, 1994 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4310 - 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 Vascular Technology Incorporated devices

Submission Details

510(k) Number K944764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1994
Decision Date December 27, 1994
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4310
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.