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FDA 510(k)

ASPIRE COVERED STENT AND DELIVERY CATHETER

K-Number: K003173 · 2001-03-13

ApplicantVascular Architects, Inc.
Decision Date2001-03-13
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASPIRE COVERED STENT AND DELIVERY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Architects, Inc.. It received FDA 510(k) clearance on 2001-03-13 under 510(k) number K003173. 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 ASPIRE COVERED STENT AND DELIVERY CATHETER?

ASPIRE COVERED STENT AND DELIVERY CATHETER is a medical device that received FDA 510(k) clearance on 2001-03-13. The listed applicant is Vascular Architects, Inc.. The 510(k) number is K003173.

When did ASPIRE COVERED STENT AND DELIVERY CATHETER receive FDA 510(k) clearance?

ASPIRE COVERED STENT AND DELIVERY CATHETER received FDA 510(k) clearance on 2001-03-13, under 510(k) number K003173.

Who is the listed applicant for ASPIRE COVERED STENT AND DELIVERY CATHETER?

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

What is the FDA product code for ASPIRE COVERED STENT AND DELIVERY CATHETER?

The FDA product code for ASPIRE COVERED STENT AND DELIVERY CATHETER is ESW.

Related Clinical Trials

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.

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Other records listing Vascular Architects, 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.

K031641VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEMK030567MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEMK012544VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEMK003719VASCULAR ARCHITECTS PERISCOPE DEVICE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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