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510(k) K931113

CADD-TPN(TM) AMBULATORY INFUSION SYSTEM by Pharmacia Deltec, Inc. — Product Code FIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1994
Date Received
March 4, 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 Pharmacia Deltec, Inc.

  • K943310 — MODEL 6100 AMBULATORY INFUSION SYSTEM (February 21, 1995)
  • K942046 — PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE (October 4, 1994)
  • K942161 — LOCKBOX (August 2, 1994)
  • K942024 — PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM (July 26, 1994)
  • K941445 — EXTENSION SET WITH ANTI-SIPHON VALVE (June 29, 1994)
  • K931073 — CATH-FINDER (May 5, 1994)
  • K932211 — PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS (May 2, 1994)
  • K932464 — PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. (May 2, 1994)
  • K932430 — DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER (May 2, 1994)
  • K932433 — PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE (May 2, 1994)

Other clearances for product code FIH

  • K932055 — PERCUPUMP II (March 21, 1995)
  • K935461 — VECTOR AMBULATORY DRUG DELIVERY SYSTEM (April 28, 1994)
  • K900439 — SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC (February 15, 1990)
  • K881707 — INTROCULAR FLUID INJECTOR (October 21, 1988)