FDA 510(k)

COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS

K-Number: K964043 · 1997-09-29

Decision Date1997-09-29

Product CodeDTZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS 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 1997-09-29 under 510(k) number K964043. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS?

COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS is a medical device that received FDA 510(k) clearance on 1997-09-29. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K964043.

When did COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS receive FDA 510(k) clearance?

COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS received FDA 510(k) clearance on 1997-09-29, under 510(k) number K964043.

Who is the listed applicant for COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS?

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 COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS?

The FDA product code for COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS is DTZ.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cobe Cardiovascular, Inc. as applicant

K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG K042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM K040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER K033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

View all 43 devices →

Related Devices (Code: DTZ)

K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)Eurosets S.R.L K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.L K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura 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.