Data / Medical devices / United States / Medtronic Perfusion Systems

Medtronic Perfusion Systems: FDA-registered device maker in Parker, CO, United States, 14 510(k) clearances

Name: Medtronic Perfusion Systems FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medtronic Perfusion Systems is registered with the FDA (registration 1718389) in Parker, CO, United States. It lists 6 device types. The FDA files 14 510(k) clearances under its listings, the newest dated October 18, 2004. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Medtronic Perfusion Systems

FDA registration number: 1718389
Address: 18501 E Plaza Dr, Parker, CO, United States, 80134
Owner or operator: Medtronic, Inc. (2112641)
Roles: Manufacturer
First device listed: March 14, 2008
Registered through: 2027
Brand names listed: ACT, ANALYZER, HEPARIN, AUTOMATED, CLOTtrac, CLOTtrac CWB, CLOTtrac HR Abnormal Control, CLOTtrac HTC, HEPtrac, HMS Control and more

Devices it lists

Device	Product code	Class	Role	Source
Activated Whole Blood Clotting Time	JBP	2	Manufacturer	accessdata.fda.gov
Analyzer, Heparin, Automated	JOX	2	Manufacturer	accessdata.fda.gov
Plasma, Coagulation Control	GGN	2	Manufacturer	accessdata.fda.gov
Protamine Sulphate	GFT	2	Manufacturer	accessdata.fda.gov
System, Multipurpose For In Vitro Coagulation Studies	JPA	2	Manufacturer	accessdata.fda.gov
Timer, Clot, Automated	GKN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 18, 2004	K042206	PURPLE/BLACK HEPARIN ASSAY CONTROL	GGN	Substantially Equivalent	Medtronic Vascular	accessdata.fda.gov
October 18, 2004	K042175	HEPARINASE HR ACT CONTROL, MODEL 550-12	GGN	Substantially Equivalent	Medtronic Vascular	accessdata.fda.gov
July 30, 1998	K981815	HEPTRAC ELECTRONIC QUALITY CONTROL	JPA	Substantially Equivalent	Medtronic Blood Management	accessdata.fda.gov
October 31, 1995	K953870	ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS	GKN	Substantially Equivalent	Medtronic Vascular	accessdata.fda.gov
September 20, 1994	K940426	MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER	GKN	Substantially Equivalent	Medtronic Hemotec, Inc.	accessdata.fda.gov
September 21, 1992	K923594	CLOTTRAC COAGULATION CONTROL	JBP	Substantially Equivalent	Medtronic Hemotec, Inc.	accessdata.fda.gov
July 21, 1992	K922031	HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL	JOX	Substantially Equivalent	Medtronic Hemotec, Inc.	accessdata.fda.gov
July 3, 1990	K902081	CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL	JBP	Substantially Equivalent	Hemotec, Inc.	accessdata.fda.gov
September 5, 1989	K894359	CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS	JPA	Substantially Equivalent	Hemotec, Inc.	accessdata.fda.gov
September 5, 1989	K894317	HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.	JOX	Substantially Equivalent	Hemotec, Inc.	accessdata.fda.gov
February 19, 1988	K880302	CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER	GGN	Substantially Equivalent	Hemotec, Inc.	accessdata.fda.gov
April 4, 1986	K860122	HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME	JBP	Substantially Equivalent	Medical Device Consultants, Inc.	accessdata.fda.gov
October 4, 1985	K853198	ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES	JPA	Substantially Equivalent	Medical Device Consultants, Inc.	accessdata.fda.gov
December 12, 1984	K843459	HEMOTEC ACT I SYSTEM	JBP	Substantially Equivalent	Hemotec, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 18, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.