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510(k) K950344

HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER by Acacia Laboratories, Inc. — Product Code FCM

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 24, 1995
Date Received
January 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Acacia Laboratories, Inc.

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  • K951861 — STERICARE WOUND CARE GEL (July 11, 1995)
  • K952414 — PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER (June 23, 1995)
  • K951914 — HYDRACARE ABSORBENT WOUND DRESSING (May 15, 1995)
  • K913408 — STERILE PLASTIC DRAPE (March 12, 1992)
  • K901761 — STERILE SUCTION TUBING SET (May 7, 1990)
  • K892856 — NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (November 8, 1989)
  • K892804 — NEWCHILL(TM) CARDIAC INSULATOR (July 14, 1989)
  • K884055 — SURGI-TAG(TM) STERILE LABEL SETS (October 13, 1988)

Other clearances for product code FCM

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  • K082831 — AMSELF CLOSED CATHETERIZATION SYSTEM (October 23, 2008)
  • K070939 — SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (June 1, 2007)
  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K030664 — AMSURE FOLEY INSERTION TRAY (May 23, 2003)
  • K030712 — AMSURE URETHRAL CATHETERIZATION TRAY (May 23, 2003)
  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K003873 — MENTOR SELF-CATH CLOSED SYSTEM (March 29, 2001)