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510(k) K971851

INTERPLEURAL ANESTHESIA CATHETER by Axiom Medical, Inc. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1998
Date Received
May 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type

Other clearances by Axiom Medical, Inc.

  • K993592 — AXIOM MULTIPURPOSE WOUND DRAIN (May 17, 2000)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)
  • K934895 — GLASSMAN SILICONE CATHETER (October 13, 1994)
  • K922760 — ATRAUM WOUND DRESSING--MODIFICATION (October 30, 1992)
  • K905422 — PVC ROUND WOUND DRAINS (February 11, 1991)
  • K904218 — SUCTION SYSTEM (October 31, 1990)
  • K904133 — DISPOSABLE FLUID COLLECTION BAG (October 11, 1990)
  • K863247 — AXIOM TROCAR THORACIC CATHETER (August 29, 1986)
  • K861306 — SUCTION SYSTEM (June 9, 1986)
  • K852614 — ATRAUM WOUND DRESSING (August 30, 1985)

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