FDA 510(k)

VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER

K-Number: K964908 · 1997-09-03

Decision Date1997-09-03

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER 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 1997-09-03 under 510(k) number K964908. 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 VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER?

VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER is a medical device that received FDA 510(k) clearance on 1997-09-03. The listed applicant is Sorin Biomedical, Inc.. The 510(k) number is K964908.

When did VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER receive FDA 510(k) clearance?

VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER received FDA 510(k) clearance on 1997-09-03, under 510(k) number K964908.

Who is the listed applicant for VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER?

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 VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER?

The FDA product code for VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER 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 K963759DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS K963758CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE 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 K952270DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN

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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.