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FDA 510(k)

DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR

K-Number: K071049 · 2007-10-16

ApplicantTyco Healthcare
Decision Date2007-10-16
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare. It received FDA 510(k) clearance on 2007-10-16 under 510(k) number K071049. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR?

DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR is a medical device that received FDA 510(k) clearance on 2007-10-16. The listed applicant is Tyco Healthcare. The 510(k) number is K071049.

When did DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR receive FDA 510(k) clearance?

DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR received FDA 510(k) clearance on 2007-10-16, under 510(k) number K071049.

Who is the listed applicant for DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR?

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

What is the FDA product code for DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR?

The FDA product code for DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR is EZL.

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Other records listing Tyco Healthcare 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.

K070685KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662K070653KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662K061492MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGEK042709DOVER SILVER TEMPERATURE SENSING FOLEY CATHETERK040897DOVER ROB-NEL CATHETERK040649KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE

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Related Devices (Code: EZL)

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.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.

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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