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510(k) K945909

NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER by Navarre Biomedical , Ltd. — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1995
Date Received
December 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
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)
  • 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)

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