FDA 510(k)

OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000

K-Number: K033830 · 2004-01-09

Decision Date2004-01-09

Product CodeEZL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 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 2004-01-09 under 510(k) number K033830. 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 WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000?

OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 is a medical device that received FDA 510(k) clearance on 2004-01-09. The listed applicant is Opticon Medical, Inc.. The 510(k) number is K033830.

When did OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 receive FDA 510(k) clearance?

OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 received FDA 510(k) clearance on 2004-01-09, under 510(k) number K033830.

Who is the listed applicant for OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000?

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 WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000?

The FDA product code for OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 is EZL.

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Other records listing Opticon Medical, Inc. as applicant

K023090OPTION-VF URINARY CATHETER, FV14218 K970716OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE K930194HEMOSTASIS VALVE AND TUBING SET K904999WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE K895955LOPER CELIAC PLEXUS BLOCK CATHETER KIT K895476OPTION EPIDURAL CATHETERS

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Related Devices (Code: EZL)

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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.