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510(k) K950438

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

K950438 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vascular Access, Inc. for the device "SAFEDWEEL DRESSING CHANGE TRAY". The FDA issued a decision of Substantially Equivalent (kit) on March 15, 1995. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Becton Dickinson Vascular Access, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K952861 — ANGIOCATH & INSYTE AUTOGUARD CATHETERS (July 31, 1995)
  • K952757 — ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE C (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

  • K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HE (July 2, 2026)
  • K252823 — Dukal Crepe Paper Sterilization Wrap (May 28, 2026)
  • K253454 — HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; (May 18, 2026)
  • 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)

FDA data resources