FDA 510(k)

VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR

K-Number: K941215 · 1995-05-10

Decision Date1995-05-10

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR 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 1995-05-10 under 510(k) number K941215. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR?

VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 1995-05-10. The listed applicant is Sorin Biomedical, Inc.. The 510(k) number is K941215.

When did VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR receive FDA 510(k) clearance?

VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR received FDA 510(k) clearance on 1995-05-10, under 510(k) number K941215.

Who is the listed applicant for VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR?

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 VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR?

The FDA product code for VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR is DTN.

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Other records listing Sorin Biomedical, Inc. as applicant

K990103MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE K963758CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE K963759DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS K964908VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER K964907VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILT K961869DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40

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Related Devices (Code: DTN)

K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mLMedtronic Cardiac Surgery K223361BMR 1900 PHISIOSorin Group Italia S.R.L.K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.

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.