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FDA 510(k)

SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K-Number: K093893 · 2010-10-05

ApplicantIdev Technologies, Inc.
Decision Date2010-10-05
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Idev Technologies, Inc.. It received FDA 510(k) clearance on 2010-10-05 under 510(k) number K093893. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM?

SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-05. The listed applicant is Idev Technologies, Inc.. The 510(k) number is K093893.

When did SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM receive FDA 510(k) clearance?

SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM received FDA 510(k) clearance on 2010-10-05, under 510(k) number K093893.

Who is the listed applicant for SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM?

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

What is the FDA product code for SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM?

The FDA product code for SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM is FGE.

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Other records listing Idev Technologies, Inc. as applicant

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K130591SUPERA VERITASK122546SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEMK111627SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEMK111766SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMSK071646SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120K060557SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060

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Related Devices (Code: FGE)

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.

K254179Drainage CatheterCanyon Medical, Inc.K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019Hangzhou AGS MedTech Co., Ltd.K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd.K251658Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH

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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