Home / 510(k) Clearances / K091488

510(k) K091488

FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C by Footprint Medical — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2009
Date Received
May 19, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Footprint Medical

  • K130507 — FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER (June 3, 2013)
  • K120304 — FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER (March 1, 2012)
  • K102548 — FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE (November 26, 2010)
  • K093026 — FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER (February 24, 2010)
  • K093252 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER (December 17, 2009)
  • K091213 — FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (September 25, 2009)
  • K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER (September 25, 2009)
  • K090576 — FOOTPRINT URINARY DRAINAGE CATHETER (August 12, 2009)
  • K090559 — FOOTPRINT MEDICAL SILICONE FEEDING TUBE (May 4, 2009)

Other clearances for product code LJS

  • K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC (December 16, 2025)
  • K252792 — PM2™ System with ECGuide™ Connector (November 17, 2025)
  • K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (700013 (August 1, 2025)
  • K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr Hyd (July 1, 2025)
  • K243484 — PM2+ System and SmartPICC Stylet (May 29, 2025)
  • K241587 — pilot TLS (February 26, 2025)
  • K241910 — Neonav ECG Tip Location System (January 19, 2025)
  • K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001 (January 17, 2025)
  • K240486 — PM2 System and ECGuide Connector (September 8, 2024)
  • K233149 — CATHTONG III Tapered PICC Catheter (December 1, 2023)