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510(k) K093431

CLEARWAY OTW MODEL 85912 by Atrium Medical Corp. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2010
Date Received
November 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Atrium Medical Corp.

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  • K113112 — CLEARWAY RX NB CATHETER (November 17, 2011)
  • K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (October 5, 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)
  • K080688 — C-QUR LITE MESH V-PATCH (April 16, 2008)

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