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FDA 510(k)

WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)

K-Number: K940396 · 1994-10-03

ApplicantBoston Scientific Scimed, Inc.
Decision Date1994-10-03
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Scimed, Inc.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K940396. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)?

WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K940396.

When did WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) receive FDA 510(k) clearance?

WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) received FDA 510(k) clearance on 1994-10-03, under 510(k) number K940396.

Who is the listed applicant for WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)?

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

What is the FDA product code for WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)?

The FDA product code for WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) is ESW.

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Other records listing Boston Scientific Scimed, Inc. as applicant

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Related Devices (Code: ESW)

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.

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific CorporationK243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston ScientificK233837Agile Esophageal Stent SystemBoston Scientific Corporation

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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