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510(k) K003173

ASPIRE COVERED STENT AND DELIVERY CATHETER by Vascular Architects, Inc. — Product Code ESW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2001
Date Received
October 10, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Esophageal
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

Other clearances by Vascular Architects, Inc.

  • K031641 — VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM (August 1, 2003)
  • K030567 — MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSIO (March 24, 2003)
  • K012544 — VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTE (November 15, 2001)
  • K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICE (February 28, 2001)

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  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K233837 — Agile Esophageal Stent System (April 4, 2024)
  • K240522 — Esophageal TTS Stent (March 22, 2024)
  • K223266 — Hilzo Esophageal Stents (January 16, 2024)
  • K221482 — Esophageal TTS Stent (June 22, 2022)
  • K211960 — Agile Esophageal OTW Stent System (November 22, 2021)
  • K213251 — HANAROSTENT Esophagus Asymmetric (CCC) (November 18, 2021)