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FDA 510(k)

KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP

K-Number: K852084 · 1985-09-20

ApplicantThe Kendal Co.
Decision Date1985-09-20
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP is the device name listed in this FDA 510(k) record. The listed applicant is The Kendal Co.. It received FDA 510(k) clearance on 1985-09-20 under 510(k) number K852084. 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 KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP?

KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP is a medical device that received FDA 510(k) clearance on 1985-09-20. The listed applicant is The Kendal Co.. The 510(k) number is K852084.

When did KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP receive FDA 510(k) clearance?

KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP received FDA 510(k) clearance on 1985-09-20, under 510(k) number K852084.

Who is the listed applicant for KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP?

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

What is the FDA product code for KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP?

The FDA product code for KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP is KOD.

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Other records listing The Kendal Co. 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.

K000087MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FRK990500KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946CK991758MONOJECT INSULIN SYRINGEK970969KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SETK951488KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAPK942664KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM

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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.

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