FDA 510(k)

VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT

K-Number: K933713 · 1994-03-01

Decision Date1994-03-01

Product CodeDTN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1994-03-01 under 510(k) number K933713. 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 VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT?

VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K933713.

When did VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT receive FDA 510(k) clearance?

VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT received FDA 510(k) clearance on 1994-03-01, under 510(k) number K933713.

Who is the listed applicant for VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT?

The FDA product code for VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT is DTN.

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Other records listing Baxter Healthcare Corp as applicant

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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.