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FDA 510(k)

COBE HEAT EXCHANGER RESERVOIR MODULE

K-Number: K812093 · 1981-08-13

ApplicantCobe Laboratories, Inc.
Decision Date1981-08-13
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE HEAT EXCHANGER RESERVOIR MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1981-08-13 under 510(k) number K812093. 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 COBE HEAT EXCHANGER RESERVOIR MODULE?

COBE HEAT EXCHANGER RESERVOIR MODULE is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K812093.

When did COBE HEAT EXCHANGER RESERVOIR MODULE receive FDA 510(k) clearance?

COBE HEAT EXCHANGER RESERVOIR MODULE received FDA 510(k) clearance on 1981-08-13, under 510(k) number K812093.

Who is the listed applicant for COBE HEAT EXCHANGER RESERVOIR MODULE?

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

What is the FDA product code for COBE HEAT EXCHANGER RESERVOIR MODULE?

The FDA product code for COBE HEAT EXCHANGER RESERVOIR MODULE is DTR.

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Other records listing Cobe Laboratories, 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902437COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER

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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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