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)

NEOCATH 1000 W/HEPCOTE

K-Number: K832793 · 1983-09-26

ApplicantOrange Medical Instruments, Inc.
Decision Date1983-09-26
Product CodeCCE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEOCATH 1000 W/HEPCOTE is the device name listed in this FDA 510(k) record. The listed applicant is Orange Medical Instruments, Inc.. It received FDA 510(k) clearance on 1983-09-26 under 510(k) number K832793. The device is classified under product code CCE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOCATH 1000 W/HEPCOTE?

NEOCATH 1000 W/HEPCOTE is a medical device that received FDA 510(k) clearance on 1983-09-26. The listed applicant is Orange Medical Instruments, Inc.. The 510(k) number is K832793.

When did NEOCATH 1000 W/HEPCOTE receive FDA 510(k) clearance?

NEOCATH 1000 W/HEPCOTE received FDA 510(k) clearance on 1983-09-26, under 510(k) number K832793.

Who is the listed applicant for NEOCATH 1000 W/HEPCOTE?

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

What is the FDA product code for NEOCATH 1000 W/HEPCOTE?

The FDA product code for NEOCATH 1000 W/HEPCOTE is CCE.

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 Orange Medical Instruments, 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.

K860808CONTINUCATHK851822BETA SCAN TRENDS METERK844796MICRO-BETA U100 SYRINGEK843882TRENDS LANCETK841369BETA SCAN DRYSTIXK833705BETAJECT BD U100

View all 12 devices →

Related Devices (Code: CCE)

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.

K935778VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEMVia Medical Corp.K912145SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIAS & W Medico TeknikK910453TOPS NEEDLE TIP PROBE & PVC TIP PROBEBaxter Healthcare CorpK905397PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEMPuritan Bennett Corp.K896311OPTEX BLOOD GAS MONITORING SYSTEMOptex BiomedicalK890624TISSUE OXYGEN MONITOR SYSTEM, MODEL IIBaxter Healthcare Corp

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.

↑