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)

HURWITZ DIALYSIS CATHETER

K-Number: K860094 · 1986-04-07

ApplicantGish Biomedical, Inc.
Decision Date1986-04-07
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HURWITZ DIALYSIS CATHETER 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 1986-04-07 under 510(k) number K860094. The device is classified under product code LFJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HURWITZ DIALYSIS CATHETER?

HURWITZ DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K860094.

When did HURWITZ DIALYSIS CATHETER receive FDA 510(k) clearance?

HURWITZ DIALYSIS CATHETER received FDA 510(k) clearance on 1986-04-07, under 510(k) number K860094.

Who is the listed applicant for HURWITZ DIALYSIS CATHETER?

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 HURWITZ DIALYSIS CATHETER?

The FDA product code for HURWITZ DIALYSIS CATHETER is LFJ.

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: LFJ)

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.

K920780MEDSURG INSERTION TRAYMedsurg Industries, Inc.K925819AKCESS0CATH KITAkcess Medical Products, Inc.K925818AKCESS-CATHAkcess Medical Products, Inc.K913468ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAYCook, Inc.K931120COAXIAL ACUTE CATHETERAkcess Medical Products, Inc.K920634SPLITTABLE SHEATH INTRODUCER SETAkcess Medical Products, Inc.

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.

↑