FDA 510(k) Applications Submitted by ICU MEDICAL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K021692 |
05/22/2002 |
CLC2000 CATHETER PATENCY DEVICE |
ICU MEDICAL, INC. |
| K970855 |
03/10/1997 |
CLAVE CONNECTOR |
ICU MEDICAL, INC. |
| K972712 |
07/21/1997 |
CORE RESISTANT HUBER INFUSION SETS |
ICU MEDICAL, INC. |
| K173477 |
11/13/2017 |
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System |
ICU Medical, Inc. |
| K040710 |
03/18/2004 |
TEGO NEEDLE FREE ACCESS ACCESS DEVICE |
ICU MEDICAL, INC. |
| K042182 |
08/11/2004 |
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 |
ICU MEDICAL, INC. |
| K033290 |
10/14/2003 |
TALON INFUSION SET, MODEL IP XXXX |
ICU MEDICAL, INC. |
| K053106 |
11/04/2005 |
TEGO, MODEL D1000 |
ICU MEDICAL, INC. |
| K051437 |
06/01/2005 |
CML 1000 |
ICU MEDICAL, INC. |
| K140129 |
01/16/2014 |
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER |
ICU MEDICAL, INC. |
| K243985 |
12/23/2024 |
RioÖ Drug Reconstitution Transfer Device |
ICU Medical, Inc. |
| K250616 |
02/28/2025 |
ClaveÖ Neutral-Displacement Needlefree Connectors |
ICU Medical, Inc. |
| K082836 |
09/26/2008 |
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES |
ICU MEDICAL, INC. |
| K242117 |
07/19/2024 |
LifeShield Infusion Safety Software Suite |
ICU Medical, Inc. |
| K223606 |
12/02/2022 |
LifeShieldÖ Infusion Safety Software Suite |
ICU Medical, Inc. |
| K964435 |
11/05/1996 |
PRIMARY IV SET |
ICU MEDICAL, INC. |
| K000472 |
02/14/2000 |
POSI-LINK |
ICU MEDICAL, INC. |
| K973167 |
08/25/1997 |
POSITIVE PRESSURE CONNECTOR |
ICU MEDICAL, INC. |
| K003513 |
11/14/2000 |
TAXOL ADMINISTRATION SET |
ICU MEDICAL, INC. |
| K974589 |
12/09/1997 |
SMARTVALVE |
ICU MEDICAL, INC. |
| K983559 |
10/13/1998 |
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR |
ICU MEDICAL, INC. |
| K052865 |
10/11/2005 |
HOSPIRA CATH LAB CONVENIENCE KITS |
ICU MEDICAL, INC. |
| K100434 |
02/16/2010 |
CLAVE NEUTRON |
ICU MEDICAL, INC. |
| K100576 |
03/01/2010 |
HIGH PRESSURE SETS-400 PSI |
ICU MEDICAL, INC. |
| K223607 |
12/02/2022 |
Plum DuoÖ Infusion System |
ICU Medical, Inc. |
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