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)

FOLEY-TEMP

K-Number: K831567 · 1983-08-10

ApplicantMallinckrodt Critical Care
Decision Date1983-08-10
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOLEY-TEMP is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1983-08-10 under 510(k) number K831567. 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 FOLEY-TEMP?

FOLEY-TEMP is a medical device that received FDA 510(k) clearance on 1983-08-10. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K831567.

When did FOLEY-TEMP receive FDA 510(k) clearance?

FOLEY-TEMP received FDA 510(k) clearance on 1983-08-10, under 510(k) number K831567.

Who is the listed applicant for FOLEY-TEMP?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOLEY-TEMP?

The FDA product code for FOLEY-TEMP 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 Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

View all 92 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.

↑