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FDA 510(k)

OPTION-VF URINARY CATHETER, FV14218

K-Number: K023090 · 2003-03-19

ApplicantOpticon Medical, Inc.
Decision Date2003-03-19
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTION-VF URINARY CATHETER, FV14218 is the device name listed in this FDA 510(k) record. The listed applicant is Opticon Medical, Inc.. It received FDA 510(k) clearance on 2003-03-19 under 510(k) number K023090. 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 OPTION-VF URINARY CATHETER, FV14218?

OPTION-VF URINARY CATHETER, FV14218 is a medical device that received FDA 510(k) clearance on 2003-03-19. The listed applicant is Opticon Medical, Inc.. The 510(k) number is K023090.

When did OPTION-VF URINARY CATHETER, FV14218 receive FDA 510(k) clearance?

OPTION-VF URINARY CATHETER, FV14218 received FDA 510(k) clearance on 2003-03-19, under 510(k) number K023090.

Who is the listed applicant for OPTION-VF URINARY CATHETER, FV14218?

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

What is the FDA product code for OPTION-VF URINARY CATHETER, FV14218?

The FDA product code for OPTION-VF URINARY CATHETER, FV14218 is EZL.

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Other records listing Opticon Medical, 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.

K033830OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000K970716OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGEK930194HEMOSTASIS VALVE AND TUBING SETK904999WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTEK895955LOPER CELIAC PLEXUS BLOCK CATHETER KITK895476OPTION EPIDURAL CATHETERS

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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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