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FDA 510(k)

HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)

K-Number: K111339 · 2011-06-08

ApplicantMedtronic, Inc.
Decision Date2011-06-08
Product CodeJOX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2011-06-08 under 510(k) number K111339. 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 HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)?

HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) is a medical device that received FDA 510(k) clearance on 2011-06-08. The listed applicant is Medtronic, Inc.. The 510(k) number is K111339.

When did HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) receive FDA 510(k) clearance?

HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) received FDA 510(k) clearance on 2011-06-08, under 510(k) number K111339.

Who is the listed applicant for HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)?

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

What is the FDA product code for HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)?

The FDA product code for HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) is JOX.

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Related Devices (Code: JOX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102953HEPARIN DOSE RESPONSE CARTRIDGEMedtronic, Inc.K101271HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XXMedtronic, Inc.K051040HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic Perfusion SystemsK043080HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMedtronic VascularK042070HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20Medtronic VascularK993519RAPIDPOINT 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.

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