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FDA 510(k)

VITALCARE FOLEY CATHETER

K-Number: K021939 · 2003-04-22

ApplicantVitalcare, Inc.
Decision Date2003-04-22
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VITALCARE FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vitalcare, Inc.. It received FDA 510(k) clearance on 2003-04-22 under 510(k) number K021939. 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 VITALCARE FOLEY CATHETER?

VITALCARE FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 2003-04-22. The listed applicant is Vitalcare, Inc.. The 510(k) number is K021939.

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

VITALCARE FOLEY CATHETER received FDA 510(k) clearance on 2003-04-22, under 510(k) number K021939.

Who is the listed applicant for VITALCARE FOLEY CATHETER?

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

What is the FDA product code for VITALCARE FOLEY CATHETER?

The FDA product code for VITALCARE FOLEY CATHETER is EZL.

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.

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Other records listing Vitalcare, 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.

K021938VITALCARE URETHRAL CATHETERK023872VITALCARE URETHRAL CATHETER RED RUBBER

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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