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510(k) K771048

CATHETERS, DRAINAGE by Axiom Medical, Inc. — Product Code FEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1977
Date Received
June 10, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

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)

Other clearances for product code FEG

  • K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression Set (August 1, 2017)
  • K132314 — MEDLINE ANTI-REFLUX VALVE (September 18, 2013)
  • K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR (January 6, 2006)
  • K040388 — NEXT GENERATION SALEM SUMP (May 17, 2004)
  • K971354 — KNOTT NG TUBE (November 19, 1997)
  • K960176 — DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER (July 24, 1996)
  • K926073 — ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE (May 15, 1995)
  • K935781 — ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY (January 27, 1995)
  • K921104 — LOPEZ VALVE WITH NG SUMP TUBE (October 26, 1992)
  • K900035 — WILSON-COOK COLON DECOMPRESSION SET (March 7, 1990)