Cleared Traditional

K944764 - VTI DISPOSABLE PRESSURE DISPLAY SET

K944764 is an FDA 510(k) clearance for VTI DISPOSABLE PRESSURE DISPLAY SET, manufactured by Vascular Technology Incorporated. The device is a Class 2 Cardiovascular device with product code DXS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K944764

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.

DXS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass

All 11
Devices cleared under the same product code (DXS) and FDA review panel - the closest regulatory comparables to K944764.
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
K113235 · Medtronic, Inc. · Dec 2011
TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
K912045 · Lifestream Int'L, Inc. · Oct 1991
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
K900797 · Shiley, Inc. · May 1990
PRESSURE BARRIER KIT CAT. NO. PBK-3
K873802 · American Omni Medical, Inc. · Nov 1987
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
K862836 · Shiley, Inc. · Sep 1986
PRESSURE DISPLAY BOX #60000/TUBING SET #61000
K852232 · Dlp, Inc. · Aug 1985