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510(k) K031641

VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM by Vascular Architects, Inc. — Product Code JCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2003
Date Received
May 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Tracheal, Expandable
Device Class
Class II
Regulation Number
878.3720
Review Panel
AN
Submission Type

Other clearances by Vascular Architects, Inc.

  • 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)
  • K003173 — ASPIRE COVERED STENT AND DELIVERY CATHETER (March 13, 2001)
  • K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICE (February 28, 2001)

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