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FDA 510(k)

NEW COBE CARDIOPLEGIA SYSTEM

K-Number: K920312 · 1992-10-01

ApplicantCobe Cardiovascular, Inc.
Decision Date1992-10-01
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEW COBE CARDIOPLEGIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Cardiovascular, Inc.. It received FDA 510(k) clearance on 1992-10-01 under 510(k) number K920312. 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 NEW COBE CARDIOPLEGIA SYSTEM?

NEW COBE CARDIOPLEGIA SYSTEM is a medical device that received FDA 510(k) clearance on 1992-10-01. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K920312.

When did NEW COBE CARDIOPLEGIA SYSTEM receive FDA 510(k) clearance?

NEW COBE CARDIOPLEGIA SYSTEM received FDA 510(k) clearance on 1992-10-01, under 510(k) number K920312.

Who is the listed applicant for NEW COBE CARDIOPLEGIA SYSTEM?

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

What is the FDA product code for NEW COBE CARDIOPLEGIA SYSTEM?

The FDA product code for NEW COBE CARDIOPLEGIA SYSTEM is DTN.

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Other records listing Cobe 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.

K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGK042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMK040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERK033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

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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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