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)

PROSTATIC URETHRO. BALLOON DILATATION CATHETER

K-Number: K873295 · 1989-07-31

ApplicantMedi-Tech, Inc.
Decision Date1989-07-31
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROSTATIC URETHRO. BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1989-07-31 under 510(k) number K873295. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTATIC URETHRO. BALLOON DILATATION CATHETER?

PROSTATIC URETHRO. BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1989-07-31. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K873295.

When did PROSTATIC URETHRO. BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

PROSTATIC URETHRO. BALLOON DILATATION CATHETER received FDA 510(k) clearance on 1989-07-31, under 510(k) number K873295.

Who is the listed applicant for PROSTATIC URETHRO. BALLOON DILATATION CATHETER?

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

What is the FDA product code for PROSTATIC URETHRO. BALLOON DILATATION CATHETER?

The FDA product code for PROSTATIC URETHRO. BALLOON DILATATION CATHETER is KOE.

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 Medi-Tech, 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.

K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERK952345MEDI-TECH PLATFORM GUIDE CATHETERK952056IMMUNOASSAY DRUGS OF ABUSE CONTROLSK945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORK942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDK943290BILIRUBIN PLUS/PEDIATRIC CONTROLS

View all 36 devices →

Related Devices (Code: KOE)

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.

K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.K924440U.S. MEDICAL PS-7000 DIALYSIS SCALEU.S. Medical 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.

↑