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FDA 510(k)

CHARGER BALLOON DILATATION CATHETER

K-Number: K112701 · 2011-10-25

ApplicantBoston Scientific
Decision Date2011-10-25
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CHARGER BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2011-10-25 under 510(k) number K112701. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHARGER BALLOON DILATATION CATHETER?

CHARGER BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2011-10-25. The listed applicant is Boston Scientific. The 510(k) number is K112701.

When did CHARGER BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

CHARGER BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2011-10-25, under 510(k) number K112701.

Who is the listed applicant for CHARGER BALLOON DILATATION CATHETER?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHARGER BALLOON DILATATION CATHETER?

The FDA product code for CHARGER BALLOON DILATATION CATHETER is FGE.

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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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