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510(k) K880072

PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM by Pharmacia Deltec, Inc. — Product Code LLD

K880072 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 29, 1988. The device falls under product code LLD (Port & Catheter, Implanted, Subcutaneous, Intraperitoneal), a Class II device regulated under 21 CFR 880.5965. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1988
Date Received
January 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
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)
  • K932433 — PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE (May 2, 1994)
  • K932211 — PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS (May 2, 1994)
  • K932198 — PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH (May 2, 1994)
  • K932464 — PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. (May 2, 1994)

Other clearances for product code LLD

  • K864552 — PORT-A-CATH IMPLANTABLE CATHETER SYSTEM (March 31, 1987)
  • K862412 — INTESTOPLANT (November 13, 1986)
  • K832906 — PORT-A-CATH IMPLANTABLE CATHETER SYS (March 6, 1984)

FDA data resources