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510(k) K952470

ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. by R-Group Intl. — Product Code GCD

K952470 is an FDA 510(k) premarket notification submitted by R-Group Intl. for the device "ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.". The FDA issued a decision of Substantially Equivalent on November 28, 1995. The device falls under product code GCD (Connector, Catheter), a Class I device regulated under 21 CFR 878.4200. R-Group Intl. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1995
Date Received
May 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by R-Group Intl.

  • K001233 — ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S (December 13, 2000)
  • K001599 — ACTI-FLEX IV ADMINISTRATION SET (September 18, 2000)
  • K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES (May 25, 2000)
  • 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 GCD

  • K940198 — L-CATH CONNECTOR ASSEMBLY (December 15, 1994)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K851196 — INCISION DRAIN (June 4, 1985)
  • K851921 — Y CONNECTOR (May 17, 1985)
  • K760524 — CATHETER CONNECTOR, ARGYLE TUBING (November 2, 1976)
  • K760382 — CONNECTORS (November 2, 1976)
  • K760203 — TUBE, STERILE NON-CONDUCTIVE CONNECTING (July 19, 1976)

FDA data resources