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FDA 510(k)

TRACER METRO SMART WIRE GUIDE

K-Number: K033754 · 2003-12-30

ApplicantWilson-Cook Medical, Inc.
Decision Date2003-12-30
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRACER METRO SMART WIRE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2003-12-30 under 510(k) number K033754. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACER METRO SMART WIRE GUIDE?

TRACER METRO SMART WIRE GUIDE is a medical device that received FDA 510(k) clearance on 2003-12-30. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K033754.

When did TRACER METRO SMART WIRE GUIDE receive FDA 510(k) clearance?

TRACER METRO SMART WIRE GUIDE received FDA 510(k) clearance on 2003-12-30, under 510(k) number K033754.

Who is the listed applicant for TRACER METRO SMART WIRE GUIDE?

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

What is the FDA product code for TRACER METRO SMART WIRE GUIDE?

The FDA product code for TRACER METRO SMART WIRE GUIDE is OCY.

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Related Devices (Code: OCY)

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.

K153264EasyPass GuidewireMedi-Globe CorporationK131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/SK124052OSTAVI HYDROPHILIC GUIDEWIRELake Region MedicalK123438XENX STONE MANAGEMENT DEVICEXenolith MedicalK123439NEO ERCP GUIDEWIRENeometrics, Inc.K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, 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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