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FDA 510(k)

WELL LEAD SILICONE AND LATEX FOLEY CATHETERS

K-Number: K082815 · 2008-10-08

ApplicantWell Lead Medical Instruments
Decision Date2008-10-08
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WELL LEAD SILICONE AND LATEX FOLEY CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Instruments. It received FDA 510(k) clearance on 2008-10-08 under 510(k) number K082815. 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 WELL LEAD SILICONE AND LATEX FOLEY CATHETERS?

WELL LEAD SILICONE AND LATEX FOLEY CATHETERS is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Well Lead Medical Instruments. The 510(k) number is K082815.

When did WELL LEAD SILICONE AND LATEX FOLEY CATHETERS receive FDA 510(k) clearance?

WELL LEAD SILICONE AND LATEX FOLEY CATHETERS received FDA 510(k) clearance on 2008-10-08, under 510(k) number K082815.

Who is the listed applicant for WELL LEAD SILICONE AND LATEX FOLEY CATHETERS?

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

What is the FDA product code for WELL LEAD SILICONE AND LATEX FOLEY CATHETERS?

The FDA product code for WELL LEAD SILICONE AND LATEX FOLEY CATHETERS is EZL.

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Other records listing Well Lead Medical Instruments 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.

K073383WELL LEAD REINFORCED ENDOTRACHEAL TUBEK042683WELL LEAD ENDOTRACHEAL TUBEK042684WELL LEAD TRACHEOSTOMY TUBE

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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