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)

DYNACOR STERILE CARELON SILICONE CATH.

K-Number: K791992 · 1979-10-26

ApplicantMedline Industries, Inc.
Decision Date1979-10-26
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DYNACOR STERILE CARELON SILICONE CATH. is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 1979-10-26 under 510(k) number K791992. 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 DYNACOR STERILE CARELON SILICONE CATH.?

DYNACOR STERILE CARELON SILICONE CATH. is a medical device that received FDA 510(k) clearance on 1979-10-26. The listed applicant is Medline Industries, Inc.. The 510(k) number is K791992.

When did DYNACOR STERILE CARELON SILICONE CATH. receive FDA 510(k) clearance?

DYNACOR STERILE CARELON SILICONE CATH. received FDA 510(k) clearance on 1979-10-26, under 510(k) number K791992.

Who is the listed applicant for DYNACOR STERILE CARELON SILICONE CATH.?

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

What is the FDA product code for DYNACOR STERILE CARELON SILICONE CATH.?

The FDA product code for DYNACOR STERILE CARELON SILICONE CATH. 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 Medline Industries, 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.

K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K222665Medline UNITE® Ankle Fusion Plating SystemK213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeK212911Konig Mogen ClampK220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser

View all 223 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.

↑