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510(k) K935461

VECTOR AMBULATORY DRUG DELIVERY SYSTEM by Infusion Technology Intl. — Product Code FIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1994
Date Received
November 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion Or Syringe, Extra-Luminal
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Infusion Technology Intl.

  • K943591 — VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM (June 28, 1995)
  • K941151 — STRATOFUSE PCA II INFUSER (July 7, 1994)

Other clearances for product code FIH

  • K932055 — PERCUPUMP II (March 21, 1995)
  • K931113 — CADD-TPN(TM) AMBULATORY INFUSION SYSTEM (April 28, 1994)
  • K900439 — SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC (February 15, 1990)
  • K881707 — INTROCULAR FLUID INJECTOR (October 21, 1988)