Cleared Traditional

K940074 - Y-TYPE BLOOD ADMINISTRATION SET
(FDA 510(k) Clearance)

K940074 · Puritas Health Care, Inc. · General Hospital

Apr 1994

Decision

105d

Days

Class 2

Risk

K940074 is an FDA 510(k) clearance for the Y-TYPE BLOOD ADMINISTRATION SET. This device is classified as a Set, Blood Transfusion (Class II — Special Controls, product code BRZ).

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on April 21, 1994, 105 days after receiving the submission on January 6, 1994.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K940074 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 1994
Decision Date	April 21, 1994
Days to Decision	105 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement