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)

CAPIOX CARDIOTOMY RESERVOIR

K-Number: K033800 · 2004-02-10

ApplicantTerumo Cardiovascular Systems Corporation
Decision Date2004-02-10
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPIOX CARDIOTOMY RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2004-02-10 under 510(k) number K033800. 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 CAPIOX CARDIOTOMY RESERVOIR?

CAPIOX CARDIOTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 2004-02-10. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K033800.

When did CAPIOX CARDIOTOMY RESERVOIR receive FDA 510(k) clearance?

CAPIOX CARDIOTOMY RESERVOIR received FDA 510(k) clearance on 2004-02-10, under 510(k) number K033800.

Who is the listed applicant for CAPIOX CARDIOTOMY RESERVOIR?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAPIOX CARDIOTOMY RESERVOIR?

The FDA product code for CAPIOX CARDIOTOMY RESERVOIR is DTN.

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 Terumo Cardiovascular Systems Corporation 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.

K234065CDI OneView Monitoring SystemK221895Terumo Advanced Perfusion System 1K200091Capiox iCP Centrifugal PumpK182110CDI Blood Parameter Monitoring System 550K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)

View all 17 devices →

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.

↑