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510(k) K971339

INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS by Becton Dickinson Vascular Access, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1997
Date Received
April 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Becton Dickinson Vascular Access, Inc.

  • K970259 — E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET (April 8, 1997)
  • K964050 — FIRST MIDCATH CATHETER (January 6, 1997)
  • K964049 — FIRST MIDCATH CATHETER WITH DUAL LUMENS (January 6, 1997)
  • K964048 — FIRST MIDCATH CATHETER KIT (January 6, 1997)
  • K954906 — FIRST PICC INTRODUCER CATHETER (April 8, 1996)
  • K952757 — ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE C (July 31, 1995)
  • K952861 — ANGIOCATH & INSYTE AUTOGUARD CATHETERS (July 31, 1995)
  • K952053 — E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS (May 31, 1995)
  • K950301 — ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS (April 18, 1995)
  • K950438 — SAFEDWEEL DRESSING CHANGE TRAY (March 15, 1995)

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