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510(k) K030567

MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM by Vascular Architects, Inc. — Product Code JCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2003
Date Received
February 24, 2003
Clearance Type
Special
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.

  • K031641 — VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM (August 1, 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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  • K152842 — WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOB (May 19, 2016)
  • K140382 — AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY (November 25, 2014)
  • K140472 — BONASTENT TRACHEAL / BRONCHIAL (October 17, 2014)
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