Home / 510(k) Clearances / K950438

510(k) K950438

SAFEDWEEL DRESSING CHANGE TRAY by Becton Dickinson Vascular Access, Inc. — Product Code FRG

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 15, 1995
Date Received
February 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Becton Dickinson Vascular Access, Inc.

  • K971339 — INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS (December 24, 1997)
  • K970259 — E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET (April 8, 1997)
  • K964050 — FIRST MIDCATH CATHETER (January 6, 1997)
  • K964048 — FIRST MIDCATH CATHETER KIT (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)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)