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510(k) K991601

DUAL LUMEN CATHETER, MODEL DL-35-90 by Endologix, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1999
Date Received
May 10, 1999
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 Endologix, Inc.

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  • K110090 — AFX INTRODUCER SYSTEM (May 26, 2011)
  • K080360 — ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER (April 8, 2008)

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