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510(k) K955505

OPTI-DRAIN MULTI-USE DRAINAGE CATHETER by Navarre Biomedical , Ltd. — Product Code GBX

K955505 is an FDA 510(k) premarket notification submitted by Navarre Biomedical , Ltd. for the device "OPTI-DRAIN MULTI-USE DRAINAGE CATHETER". The FDA issued a decision of Substantially Equivalent on February 7, 1996. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Navarre Biomedical , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1996
Date Received
December 1, 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)
  • K945909 — NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER (June 2, 1995)
  • K951907 — NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER (May 15, 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)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • 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)

FDA data resources