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)

CPS-3000 CARDIOPLEGIA RESERVOIR

K-Number: K861102 · 1986-05-28

ApplicantGish Biomedical, Inc.
Decision Date1986-05-28
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPS-3000 CARDIOPLEGIA RESERVOIR 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 1986-05-28 under 510(k) number K861102. 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 CPS-3000 CARDIOPLEGIA RESERVOIR?

CPS-3000 CARDIOPLEGIA RESERVOIR is a medical device that received FDA 510(k) clearance on 1986-05-28. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K861102.

When did CPS-3000 CARDIOPLEGIA RESERVOIR receive FDA 510(k) clearance?

CPS-3000 CARDIOPLEGIA RESERVOIR received FDA 510(k) clearance on 1986-05-28, under 510(k) number K861102.

Who is the listed applicant for CPS-3000 CARDIOPLEGIA RESERVOIR?

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 CPS-3000 CARDIOPLEGIA RESERVOIR?

The FDA product code for CPS-3000 CARDIOPLEGIA RESERVOIR 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 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: 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.

↑