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 CATHETER TEMPERATURE SENSOR

K-Number: K873448 · 1987-12-07

ApplicantRespiratory Support Products, Inc.
Decision Date1987-12-07
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOLEY CATHETER TEMPERATURE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Respiratory Support Products, Inc.. It received FDA 510(k) clearance on 1987-12-07 under 510(k) number K873448. 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 CATHETER TEMPERATURE SENSOR?

FOLEY CATHETER TEMPERATURE SENSOR is a medical device that received FDA 510(k) clearance on 1987-12-07. The listed applicant is Respiratory Support Products, Inc.. The 510(k) number is K873448.

When did FOLEY CATHETER TEMPERATURE SENSOR receive FDA 510(k) clearance?

FOLEY CATHETER TEMPERATURE SENSOR received FDA 510(k) clearance on 1987-12-07, under 510(k) number K873448.

Who is the listed applicant for FOLEY CATHETER TEMPERATURE SENSOR?

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

What is the FDA product code for FOLEY CATHETER TEMPERATURE SENSOR?

The FDA product code for FOLEY CATHETER TEMPERATURE SENSOR 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 Respiratory Support Products, 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.

K983862CLOUD 1 HUMIDIFICATION SYSTEMK921190ADAP-TEMP TEMPERATURE SENSOR ADAPTERK920469MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIEK921510GAS SAMPLING KIT MODIFICATIONK913082BI-TEMP TEMPERATURE MONITOR,MODEL TM-300DK912280BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D

View all 27 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.

↑