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FDA 510(k)

BARDEX LUBRI-SIL FOLEY CATHETER

K-Number: K984084 · 1999-02-01

ApplicantBard Medical Div.
Decision Date1999-02-01
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARDEX LUBRI-SIL FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bard Medical Div.. It received FDA 510(k) clearance on 1999-02-01 under 510(k) number K984084. 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 BARDEX LUBRI-SIL FOLEY CATHETER?

BARDEX LUBRI-SIL FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1999-02-01. The listed applicant is Bard Medical Div.. The 510(k) number is K984084.

When did BARDEX LUBRI-SIL FOLEY CATHETER receive FDA 510(k) clearance?

BARDEX LUBRI-SIL FOLEY CATHETER received FDA 510(k) clearance on 1999-02-01, under 510(k) number K984084.

Who is the listed applicant for BARDEX LUBRI-SIL FOLEY CATHETER?

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

What is the FDA product code for BARDEX LUBRI-SIL FOLEY CATHETER?

The FDA product code for BARDEX LUBRI-SIL 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 Bard Medical Div. 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.

K984136BARDEX LUBRI-SIL I.C. FOLEY CATHETERK970110BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)

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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