Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1718389

FEI Number

1718389

Entity Name

MEDTRONIC PERFUSION SYSTEMS

City/State/Country

PARKER, CO, US

Establishment Address

18501 E Plaza Dr, PARKER, CO 80134, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K981815

PMA Number

N/A

All Registered Proprietary Names

CLOTtrac CWB CLOTtrac HR Abnormal Control LR-ACT SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES CLOTtrac Heparin Assay 4 CH ACT ANALYZER, HEPARIN, AUTOMATED CLOTtrac HTC HMS Control HEPtrac

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2008-03-14
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2008-03-14
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2008-03-14
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2016-09-01
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2008-03-14
JOX	Analyzer, Heparin, Automated	Hematology	Class 2	864.5680	2008-03-14
GKN	Timer, Clot, Automated	Hematology	Class 2	864.5400	2008-03-14
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2016-09-01
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2008-03-14
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2008-03-14
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2017-10-05
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2008-03-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, 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
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18
K021022	Instrumentation Laboratory CO	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	2002-05-14
K113211	Instrumentation Laboratory CO	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	2012-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05	bioMerieux	2	The MDA system with MDA Antithrombin III MDA Heparin
Z-0736-04	Instrumentation Laboratory Co.	2	ACL Futura Instrument Analyzer
Z-0737-04	Instrumentation Laboratory Co.	2	ACL Advance Instrument Analyzer

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1718389. Last updated year: 2026. Please use registration number 1718389 when referencing this establishment in official correspondence.