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FDA 510(k)

CLOTTRAC COAGULATION CONTROL

K-Number: K923594 · 1992-09-21

ApplicantMedtronic Hemotec, Inc.
Decision Date1992-09-21
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLOTTRAC COAGULATION CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Hemotec, Inc.. It received FDA 510(k) clearance on 1992-09-21 under 510(k) number K923594. The device is classified under product code JBP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOTTRAC COAGULATION CONTROL?

CLOTTRAC COAGULATION CONTROL is a medical device that received FDA 510(k) clearance on 1992-09-21. The listed applicant is Medtronic Hemotec, Inc.. The 510(k) number is K923594.

When did CLOTTRAC COAGULATION CONTROL receive FDA 510(k) clearance?

CLOTTRAC COAGULATION CONTROL received FDA 510(k) clearance on 1992-09-21, under 510(k) number K923594.

Who is the listed applicant for CLOTTRAC COAGULATION CONTROL?

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

What is the FDA product code for CLOTTRAC COAGULATION CONTROL?

The FDA product code for CLOTTRAC COAGULATION CONTROL is JBP.

Related Clinical Trials

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Other records listing Medtronic 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.

K954202PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMSK944115HEPARIN ASSAY CARTRIDGES AND CONTROLSK940426MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMERK922031HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL

Related Devices (Code: JBP)

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.

K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.K062604RAPIDTEG TEG-ACT TESTHaemoscope Corp.K032952AIACT KITSienco, Inc.K023582I-STAT KAOLIN ACT TESTI-Stat CorporationK020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena LaboratoriesK013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena Laboratories

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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