Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA

K-Number: K944267 · 1995-04-28

ApplicantCobe Cardiovascular, Inc.
Decision Date1995-04-28
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA 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 1995-04-28 under 510(k) number K944267. 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 HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA?

HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA is a medical device that received FDA 510(k) clearance on 1995-04-28. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K944267.

When did HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA receive FDA 510(k) clearance?

HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA received FDA 510(k) clearance on 1995-04-28, under 510(k) number K944267.

Who is the listed applicant for HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA?

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 HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA?

The FDA product code for HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA is DTR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 43 devices →

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.

↑