Cleared Abbreviated

PENTATRASFU BLOOD TRANSFUSION SETS

K041496 · Pentaferte S.P.A · General Hospital

Jun 2005

Decision

391d

Days

Class 2

Risk

About This 510(k) Submission

K041496 is an FDA 510(k) clearance for the PENTATRASFU BLOOD TRANSFUSION SETS, a Set, Blood Transfusion (Class II — Special Controls, product code BRZ), submitted by Pentaferte S.P.A (Parkland, US). The FDA issued a Cleared decision on June 30, 2005, 391 days after receiving the submission on June 4, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K041496 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2004
Decision Date	June 30, 2005
Days to Decision	391 days
Submission Type	Abbreviated
Review Panel	General Hospital (HO)
Summary	Summary PDF