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)

CATHETER, AKRON FOLEY TEFLON

K-Number: K781751 · 1979-01-22

ApplicantLatex Ind., Inc.
Decision Date1979-01-22
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER, AKRON FOLEY TEFLON is the device name listed in this FDA 510(k) record. The listed applicant is Latex Ind., Inc.. It received FDA 510(k) clearance on 1979-01-22 under 510(k) number K781751. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, AKRON FOLEY TEFLON?

CATHETER, AKRON FOLEY TEFLON is a medical device that received FDA 510(k) clearance on 1979-01-22. The listed applicant is Latex Ind., Inc.. The 510(k) number is K781751.

When did CATHETER, AKRON FOLEY TEFLON receive FDA 510(k) clearance?

CATHETER, AKRON FOLEY TEFLON received FDA 510(k) clearance on 1979-01-22, under 510(k) number K781751.

Who is the listed applicant for CATHETER, AKRON FOLEY TEFLON?

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

What is the FDA product code for CATHETER, AKRON FOLEY TEFLON?

The FDA product code for CATHETER, AKRON FOLEY TEFLON is KOD.

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 Latex Ind., 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.

K812058AKRON URINARY DRAINAGE BATK810281UROLOGICAL CATHETERSK791674BLADDER RETENTION CATHETERIZATION TRAYK781433AKRON MALE EXTERNAL CATHETERK772277BLADDER RETENTION-CATHETHERIZATIONTRAYK772341BLADDER KIT - 734000

View all 14 devices →

Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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.

↑