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FDA 510(k)

JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM

K-Number: K943803 · 1996-01-30

ApplicantJanus Biomedical, Inc.
Decision Date1996-01-30
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Janus Biomedical, Inc.. It received FDA 510(k) clearance on 1996-01-30 under 510(k) number K943803. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM?

JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-30. The listed applicant is Janus Biomedical, Inc.. The 510(k) number is K943803.

When did JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM receive FDA 510(k) clearance?

JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM received FDA 510(k) clearance on 1996-01-30, under 510(k) number K943803.

Who is the listed applicant for JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM?

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

What is the FDA product code for JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM?

The FDA product code for JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM is DTQ.

Related Clinical Trials

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.

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Other records listing Janus Biomedical, 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.

K915471CRYOBAG

Related Devices (Code: DTQ)

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.

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century Perfusion SystemCentury Hlm, LLCK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.

Official Source

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

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