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510(k) K841593

AXIOM THORACIC CATHETERS by Axiom Medical, Inc.

K841593 is an FDA 510(k) premarket notification submitted by Axiom Medical, Inc. for the device "AXIOM THORACIC CATHETERS". The FDA issued a decision of Substantially Equivalent on June 5, 1984. Axiom Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1984
Date Received
April 18, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Axiom Medical, Inc.

  • K993592 — AXIOM MULTIPURPOSE WOUND DRAIN (May 17, 2000)
  • K971851 — INTERPLEURAL ANESTHESIA CATHETER (January 22, 1998)
  • 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)

FDA data resources