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FDA 510(k)

MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

K-Number: K012898 · 2001-09-17

ApplicantCobe Cardiovascular, Inc.
Decision Date2001-09-17
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: CSC14 BLOOD 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 2001-09-17 under 510(k) number K012898. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM?

MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-17. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K012898.

When did MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM received FDA 510(k) clearance on 2001-09-17, under 510(k) number K012898.

Who is the listed applicant for MODIFICATION TO: CSC14 BLOOD 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 MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM?

The FDA product code for MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM is DTR.

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Other records listing Cobe Cardiovascular, Inc. as applicant

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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: DTR)

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.

K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical , Ltd.K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)Sorin Group Italia S.R.L.K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronicK223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura 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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