Cleared Traditional

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

K944764 · Vascular Technology Incorporated · Cardiovascular

Dec 1994

Decision

91d

Days

Class 2

Risk

K944764 is an FDA 510(k) clearance for the VTI DISPOSABLE PRESSURE DISPLAY SET, a Gauge, Pressure, Coronary, Cardiopulmonary Bypass (Class II — Special Controls, product code DXS), submitted by Vascular Technology Incorporated (Chelmsford, US). The FDA issued a Cleared decision on December 27, 1994, 91 days after receiving the submission on September 27, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4310.

Submission Details

510(k) Number	K944764 FDA.gov
FDA Decision	Cleared 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