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FDA 510(k)

SORIN BLOOD CARDIOPLEGIA CONSOLE

K-Number: K942582 · 1995-01-27

ApplicantSorin Biomedical, Inc.
Decision Date1995-01-27
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SORIN BLOOD CARDIOPLEGIA CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedical, Inc.. It received FDA 510(k) clearance on 1995-01-27 under 510(k) number K942582. 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 SORIN BLOOD CARDIOPLEGIA CONSOLE?

SORIN BLOOD CARDIOPLEGIA CONSOLE is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Sorin Biomedical, Inc.. The 510(k) number is K942582.

When did SORIN BLOOD CARDIOPLEGIA CONSOLE receive FDA 510(k) clearance?

SORIN BLOOD CARDIOPLEGIA CONSOLE received FDA 510(k) clearance on 1995-01-27, under 510(k) number K942582.

Who is the listed applicant for SORIN BLOOD CARDIOPLEGIA CONSOLE?

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

What is the FDA product code for SORIN BLOOD CARDIOPLEGIA CONSOLE?

The FDA product code for SORIN BLOOD CARDIOPLEGIA CONSOLE is DTQ.

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Other records listing Sorin 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.

K990103MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHEK963758CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINEK963759DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMSK964908VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTERK964907VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILTK961869DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40

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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

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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