Home / 510(k) Clearances / K093489

510(k) K093489

IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY by Rymed Technologies, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2010
Date Received
November 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Rymed Technologies, Inc.

  • K162826 — Encore Neutral (June 15, 2017)
  • K991653 — INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM (June 24, 1999)
  • K960771 — SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM (December 10, 1996)

Other clearances for product code FPA

  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)
  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
  • K242692 — SteadiSet Infusion Set (May 9, 2025)
  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)