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FDA 510(k)

GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR

K-Number: K964973 · 1997-03-10

ApplicantGish Biomedical, Inc.
Decision Date1997-03-10
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1997-03-10 under 510(k) number K964973. 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 GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR?

GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR is a medical device that received FDA 510(k) clearance on 1997-03-10. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K964973.

When did GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR receive FDA 510(k) clearance?

GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR received FDA 510(k) clearance on 1997-03-10, under 510(k) number K964973.

Who is the listed applicant for GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR?

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

What is the FDA product code for GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR?

The FDA product code for GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR is DTN.

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Other records listing Gish Biomedical, Inc. as applicant

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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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