Home / 510(k) Clearances / K100282

510(k) K100282

TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER by Terumo Corp. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2010
Date Received
February 1, 2010
Clearance Type
Special
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 Terumo Corp.

  • K092372 — HEARTRAIL III GUIDING CATHETER (September 11, 2009)
  • K091417 — SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, (May 22, 2009)
  • K090973 — TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) (May 1, 2009)
  • K073474 — CAPIOX CIRCUIT CONNECTORS (March 5, 2008)
  • K071572 — CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER (July 23, 2007)
  • K071494 — CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER (July 16, 2007)
  • K071075 — TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A (May 25, 2007)
  • K040783 — FOUNDATION (October 13, 2004)
  • K040210 — CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR (March 3, 2004)
  • K033681 — GLIDESHEATH (December 11, 2003)

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)