Home / 510(k) Clearances / K971990

510(k) K971990

GESCO PER-Q-CATH PICC CATHETERS by Bard Access Systems, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1997
Date Received
May 9, 1997
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 Bard Access Systems, Inc.

  • K252478 — Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Inj (September 5, 2025)
  • K251253 — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M. (June 18, 2025)
  • K241353 — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (November 27, 2024)
  • K242328 — PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implan (October 31, 2024)
  • K240146 — BD Prevue™ II Peripheral Vascular Access System (February 18, 2024)
  • K223198 — BD Intraosseous Vascular Access System EMS Powered Driver (D001003) (November 10, 2022)
  • K222232 — Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly (August 24, 2022)
  • K210264 — BD PowerPiCC Catheter (July 30, 2021)
  • K120882 — SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE (May 30, 2012)
  • K100402 — SITE-RITE VISION ULTRASOUND SYSTEM (March 5, 2010)

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)