Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1713468

FEI Number

1713468

Entity Name

ICU MEDICAL, INC

City/State/Country

Salt Lake City, UT, US

Establishment Address

4455 ATHERTON DR., Salt Lake City, UT 84123, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ICU MEDICAL, INC. (Owner Number: 2025816)

Owner / Operator Contact Address

951 Calle Amanecer, --, San Clemente, CA 92673, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K915171

PMA Number

N/A

All Registered Proprietary Names

CLAVE Stopcock SwabCap Expressions MR Transpac IV Cardiac Catheterization Kit Smartvalve Cardiac Catheterization Kit Graduated Adapter With CLAVE CVP CATHETER Pull Tab Squeeze Flush ChemoCLAVE Prep System Diana Compounding Workflow System Diana Antimicrobial CLAVE Opticath, Heparin Coated High Pressure Tubing Safeset SwabCap TriOX OPTICATH® CENTRAL VENOUS OXIMETRY CATHETER Spiros Neutron Transpac IT ChemoLock ChemoPort Diana ChemoLock Transfer Set Vital Signs Wireless Monitoring System Spinning Spiros SHIELDED BLUNT CANNULA PRESSURE INFUSION CUFF Advanced Sensor Catheter Dye Management System Cogent Hemodynamic Monitoring System High Pressure Sets Syringe Adaptor CLAVE Connector Single Lead Dispensing Set Opticath Catheter, oximeter, fiber-optic CVP Polyurethane Catheter W Heparin (No Balloon) Lopez Valve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2008-09-22
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2008-09-22
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2016-03-01
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2010-02-07
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-02-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	1999-08-04
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-02-18
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2008-09-22
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2008-09-22
GBP	Catheter, Multiple Lumen	General, Plastic Surgery	Class 1	878.4200	1999-01-12
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2008-09-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-09-22
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2008-09-22
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2011-11-08
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2010-02-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-02-18
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2010-11-23
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-06-16
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2010-02-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-02-18
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2016-03-01
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2010-02-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-09-22
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2010-07-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-07-16
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2010-02-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-08-21
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2013-08-21
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2019-02-21
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2010-02-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-02-18
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	1999-01-12
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	1995-08-01
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2010-02-15
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2010-02-15
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2010-02-15
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-10-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-05-12
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2017-05-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-01-11
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2016-03-01
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	1999-08-04
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2016-03-01
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2010-09-22
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2010-02-15
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2010-02-15
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2010-02-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2010-02-18
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2010-02-18

Official Correspondent

Michelle Doherty

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ICU MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9617594	ICU MEDICAL DE MEXICO, S. de R.L. de C.V.	ENSENADA, Baja California, MX
2025816	ICU MEDICAL, INC.	SAN CLEMENTE, CA, US
2024064	ICU MEDICAL, INC.	SAN DIEGO, CA, US
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US
9615050	ICU Medical Costa Rica Ltd.	La Aurora de Heredia, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1713468. Last updated year: 2026. Please use registration number 1713468 when referencing this establishment in official correspondence.