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FDA 510(k)

AFFINITY VENOUS RESERVIOR BAG

K-Number: K935717 · 1994-05-10

ApplicantAvecor Cardiovascular, Inc.
Decision Date1994-05-10
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AFFINITY VENOUS RESERVIOR BAG is the device name listed in this FDA 510(k) record. The listed applicant is Avecor Cardiovascular, Inc.. It received FDA 510(k) clearance on 1994-05-10 under 510(k) number K935717. 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 AFFINITY VENOUS RESERVIOR BAG?

AFFINITY VENOUS RESERVIOR BAG is a medical device that received FDA 510(k) clearance on 1994-05-10. The listed applicant is Avecor Cardiovascular, Inc.. The 510(k) number is K935717.

When did AFFINITY VENOUS RESERVIOR BAG receive FDA 510(k) clearance?

AFFINITY VENOUS RESERVIOR BAG received FDA 510(k) clearance on 1994-05-10, under 510(k) number K935717.

Who is the listed applicant for AFFINITY VENOUS RESERVIOR BAG?

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

What is the FDA product code for AFFINITY VENOUS RESERVIOR BAG?

The FDA product code for AFFINITY VENOUS RESERVIOR BAG is DTN.

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Other records listing Avecor Cardiovascular, 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.

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Related Devices (Code: DTN)

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.

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 SurgeryK223361BMR 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

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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