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510(k) K970259

E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET by Becton Dickinson Vascular Access, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1997
Date Received
January 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Becton Dickinson Vascular Access, Inc.

  • K971339 — INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS (December 24, 1997)
  • K964048 — FIRST MIDCATH CATHETER KIT (January 6, 1997)
  • K964050 — FIRST MIDCATH CATHETER (January 6, 1997)
  • K964049 — FIRST MIDCATH CATHETER WITH DUAL LUMENS (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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