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510(k) K113112

CLEARWAY RX NB CATHETER by Atrium Medical Corp. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2011
Date Received
October 20, 2011
Clearance Type
Special
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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  • 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)
  • K080688 — C-QUR LITE MESH V-PATCH (April 16, 2008)

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