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FDA 510(k)

TRIVEX SYSTEM

K-Number: K032387 · 2003-10-29

ApplicantSmith & Nephew, Inc.
Decision Date2003-10-29
Product CodeDWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRIVEX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2003-10-29 under 510(k) number K032387. The device is classified under product code DWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIVEX SYSTEM?

TRIVEX SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-29. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K032387.

When did TRIVEX SYSTEM receive FDA 510(k) clearance?

TRIVEX SYSTEM received FDA 510(k) clearance on 2003-10-29, under 510(k) number K032387.

Who is the listed applicant for TRIVEX SYSTEM?

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

What is the FDA product code for TRIVEX SYSTEM?

The FDA product code for TRIVEX SYSTEM is DWQ.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: DWQ)

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.

K212894PhasTIPPLeMaitre Vascular, Inc.K041453SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023Smith & Nephew, Inc.K905528URESIL VALVE CUTTERUresil Corp.K904507PILLING BRUSH VALVULOTOMEPilling Co.K885046INSITUCAT VALVE STRIPPERAesculap Instruments Corp.K872157HALL VEIN STRIPPERSolco Basle, 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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