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510(k) K051332

ADVANTA T-GRAFT by Atrium Medical Corp. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2005
Date Received
May 23, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

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  • K113112 — CLEARWAY RX NB CATHETER (November 17, 2011)
  • K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (October 5, 2010)
  • K093431 — CLEARWAY OTW MODEL 85912 (April 20, 2010)
  • K100076 — ATRIUM C-QUR OVT MESH (January 26, 2010)
  • K090909 — C-QUR V -PATCH MESH (June 4, 2009)
  • K082748 — ATRIUM PROLITE S MESH (January 14, 2009)
  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)

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