FDA 510(k)

HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

K-Number: K051040 · 2005-05-24

Decision Date2005-05-24

Product CodeJOX

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Perfusion Systems. It received FDA 510(k) clearance on 2005-05-24 under 510(k) number K051040. The device is classified under product code JOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR?

HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR is a medical device that received FDA 510(k) clearance on 2005-05-24. The listed applicant is Medtronic Perfusion Systems. The 510(k) number is K051040.

When did HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR receive FDA 510(k) clearance?

HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR received FDA 510(k) clearance on 2005-05-24, under 510(k) number K051040.

Who is the listed applicant for HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR?

The FDA 510(k) record lists Medtronic Perfusion Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR?

The FDA product code for HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR is JOX.

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Related Devices (Code: JOX)

K111339HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)Medtronic, Inc.K102953HEPARIN DOSE RESPONSE CARTRIDGEMedtronic, Inc.K101271HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XXMedtronic, Inc.K043080HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic Vascular K042070HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20Medtronic Vascular K993519RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TESTCardiovascular Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.