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510(k) K931113

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

K931113 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "CADD-TPN(TM) AMBULATORY INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 1994. The device falls under product code FIH (Pump, Infusion Or Syringe, Extra-Luminal), a Class II device regulated under 21 CFR 876.5820. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K932464 — PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. (May 2, 1994)
  • K932211 — PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS (May 2, 1994)
  • K932433 — PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE (May 2, 1994)
  • K932198 — PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH (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)

FDA data resources