Cleared Traditional

K912045 - TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
(FDA 510(k) Clearance)

K912045 · Lifestream Int'L, Inc. · Cardiovascular

Oct 1991

Decision

176d

Days

Class 2

Risk

K912045 is an FDA 510(k) clearance for the TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST. This device is classified as a Gauge, Pressure, Coronary, Cardiopulmonary Bypass (Class II — Special Controls, product code DXS).

Submitted by Lifestream Int'L, Inc. (The Woodlands, US). The FDA issued a Cleared decision on October 31, 1991, 176 days after receiving the submission on May 8, 1991.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4310.

Submission Details

510(k) Number	K912045 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 1991
Decision Date	October 31, 1991
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF