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)

CARDIOTOMY RESERVOIR BRS-XXX SERIES &

K-Number: K843888 · 1985-02-14

ApplicantGish Biomedical, Inc.
Decision Date1985-02-14
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTOMY RESERVOIR BRS-XXX SERIES & is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1985-02-14 under 510(k) number K843888. 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 CARDIOTOMY RESERVOIR BRS-XXX SERIES &?

CARDIOTOMY RESERVOIR BRS-XXX SERIES & is a medical device that received FDA 510(k) clearance on 1985-02-14. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K843888.

When did CARDIOTOMY RESERVOIR BRS-XXX SERIES & receive FDA 510(k) clearance?

CARDIOTOMY RESERVOIR BRS-XXX SERIES & received FDA 510(k) clearance on 1985-02-14, under 510(k) number K843888.

Who is the listed applicant for CARDIOTOMY RESERVOIR BRS-XXX SERIES &?

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

What is the FDA product code for CARDIOTOMY RESERVOIR BRS-XXX SERIES &?

The FDA product code for CARDIOTOMY RESERVOIR BRS-XXX SERIES & 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 Gish Biomedical, 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.

K090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LTK090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTK091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730K083131MEDOS HILITE RESERVOIR, MODEL: 4030K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTK082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING

View all 75 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.

↑