Cleared Traditional

NEOCARE 20 MICRON BLOOD FILTER

K000719 · Whatman, Inc. · General Hospital

May 2000

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K000719 is an FDA 510(k) clearance for the NEOCARE 20 MICRON BLOOD FILTER, a Microfilter, Blood Transfusion (Class II — Special Controls, product code CAK), submitted by Whatman, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on May 30, 2000, 88 days after receiving the submission on March 3, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K000719 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2000
Decision Date	May 30, 2000
Days to Decision	88 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement