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FDA 510(k)

HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.

K-Number: K894317 · 1989-09-05

ApplicantHemotec, Inc.
Decision Date1989-09-05
Product CodeJOX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. is the device name listed in this FDA 510(k) record. The listed applicant is Hemotec, Inc.. It received FDA 510(k) clearance on 1989-09-05 under 510(k) number K894317. 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 HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.?

HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. is a medical device that received FDA 510(k) clearance on 1989-09-05. The listed applicant is Hemotec, Inc.. The 510(k) number is K894317.

When did HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. receive FDA 510(k) clearance?

HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. received FDA 510(k) clearance on 1989-09-05, under 510(k) number K894317.

Who is the listed applicant for HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.?

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

What is the FDA product code for HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.?

The FDA product code for HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. is JOX.

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Other records listing Hemotec, Inc. as applicant

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.

K902081CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROLK894359CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLSK894466HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLSK884590HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGESK875089HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARINK880302CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER

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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.

K111339HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)Medtronic, Inc.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 Vascular

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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