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510(k) K951907

NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER by Navarre Biomedical , Ltd. — Product Code GBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
April 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Navarre Biomedical , Ltd.

  • K955110 — NAVARRE PERCUTANEOUS BILIARY DRAINAGE (November 7, 1996)
  • K955505 — OPTI-DRAIN MULTI-USE DRAINAGE CATHETER (February 7, 1996)
  • K945909 — NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER (June 2, 1995)
  • K951475 — NAVARRE UNIVERSAL DRAINAGE CATHETER (April 24, 1995)
  • K943663 — NAVARRE 600 ML DRAINAGE BAG (September 8, 1994)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K933600 — NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS (March 28, 1994)
  • K932391 — NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET (January 27, 1994)

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  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)