Cleared Abbreviated

COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM

K042473 · Cobe Cardiovascular, Inc. · Hematology
Nov 2004
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K042473 is an FDA 510(k) clearance for the COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM, a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I — General Controls, product code JQC), submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on November 19, 2004, 67 days after receiving the submission on September 13, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K042473 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2004
Decision Date November 19, 2004
Days to Decision 67 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JQC — Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050

Similar Devices — JQC Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

All 37
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
K183205 · Emcyte Corporation · May 2019
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
K103340 · Harvest Technologies, Corp. · Dec 2010
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
K081345 · Thermogenesis Corp. · Jul 2008
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
K071934 · Biomet Manufacturing Corp · Oct 2007
GENESISCS COMPONENT CONCENTRATING SYSTEM
K070666 · Perfusion Partners & Assoc., Inc. · Jun 2007
SMARTPREP2 CENTRIFUGE SYSTEM
K052925 · Harvest Technologies, Corp. · Jan 2006