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510(k) K111747

ENDOLOGIX AFX INTRODUCER SYSTEM by Endologix, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2011
Date Received
June 22, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Endologix, Inc.

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  • K110090 — AFX INTRODUCER SYSTEM (May 26, 2011)
  • K080360 — ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER (April 8, 2008)
  • K991601 — DUAL LUMEN CATHETER, MODEL DL-35-90 (October 28, 1999)

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