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FDA 510(k)

WALLSTENT ENTERAL ENDOPROTHESIS

K-Number: K954290 · 1996-07-10

ApplicantBoston Scientific Scimed, Inc.
Decision Date1996-07-10
Product CodeMQR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WALLSTENT ENTERAL ENDOPROTHESIS 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 1996-07-10 under 510(k) number K954290. The device is classified under product code MQR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALLSTENT ENTERAL ENDOPROTHESIS?

WALLSTENT ENTERAL ENDOPROTHESIS is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K954290.

When did WALLSTENT ENTERAL ENDOPROTHESIS receive FDA 510(k) clearance?

WALLSTENT ENTERAL ENDOPROTHESIS received FDA 510(k) clearance on 1996-07-10, under 510(k) number K954290.

Who is the listed applicant for WALLSTENT ENTERAL ENDOPROTHESIS?

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 ENTERAL ENDOPROTHESIS?

The FDA product code for WALLSTENT ENTERAL ENDOPROTHESIS is MQR.

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Other records listing Boston Scientific Scimed, Inc. as applicant

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.

K041727MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456K030617PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIREK024048MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEMK021735BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETERK021901WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMK012822MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX

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Related Devices (Code: MQR)

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.

K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemBoston Scientific CorporationK201159WallFlex Colonic Stent System with Anchor Lock Delivery SystemBoston Scientific CorporationK200257WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemBoston Scientific CorporationK190141HANAROSTENT LowAx Colon/Rectum (NNN)M.I.Tech Co., Ltd.K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)M.I.Tech Co., Ltd.

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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