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510(k) K003288

ORIGEN DUAL LUMEN CATHETER by Origen Biomedical, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2001
Date Received
October 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Origen Biomedical, Inc.

  • K113869 — ORIGEN REINFORCED DUAL LUMEN CATHETER (July 26, 2012)
  • K021702 — CRYOBAG, MODEL CB (August 6, 2002)
  • K003145 — ORIGEN BLADDER HOLDER (April 20, 2001)

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