Home / 510(k) Clearances / K932946

510(k) K932946

WALLACE IV CANNULA by Smiths Industries Medical Systems, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1995
Date Received
June 17, 1993
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 Smiths Industries Medical Systems, Inc.

  • K972385 — FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED (January 20, 1998)
  • K965017 — REGIONAL ANESTHESIA TRAYS (March 14, 1997)
  • K962175 — PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE (January 17, 1997)
  • K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT (October 21, 1996)
  • K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (October 18, 1996)
  • K960429 — PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. IN (May 2, 1996)
  • K953485 — SIMS CPAP SYSTEM (October 26, 1995)
  • K953483 — SIMS BLUE LINE ENDOBRONCHIAL TUBE (October 24, 1995)
  • K932947 — WALLACE Y-CAN (September 1, 1995)
  • K952516 — PRO-VENT, LINE DRAW, PULSATOR (July 14, 1995)

Other clearances for product code FOZ

  • K252398 — SURFLO Hybria Closed System Safety IV Catheter (December 17, 2025)
  • K252677 — Polyshield Safety IV Catheters (November 5, 2025)
  • K251422 — BD Saf-T-Intima™ Subcutaneous Catheter System (October 8, 2025)
  • K243403 — BD Nexiva™ Closed IV Catheter System (July 25, 2025)
  • K251155 — BD Cathena™ Safety IV Catheter (July 11, 2025)
  • K251654 — BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV (June 27, 2025)
  • K250682 — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed (June 3, 2025)
  • K243105 — Ruby Intravascular Catheter (May 16, 2025)
  • K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (May 2, 2025)
  • K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual (March 27, 2025)