Home / 510(k) Clearances / K001599

510(k) K001599

ACTI-FLEX IV ADMINISTRATION SET by R-Group Intl. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2000
Date Received
May 24, 2000
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 R-Group Intl.

  • K001233 — ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S (December 13, 2000)
  • K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (May 25, 2000)
  • K952470 — ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (November 28, 1995)
  • K954035 — ACTI-FLEX ARTERIAL EXTENSION SET (September 25, 1995)
  • K940319 — R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE (November 10, 1994)
  • K913267 — R-GROUP INTL. ONE WALL PUNCTURE NEEDLE (June 5, 1992)

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)