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510(k) K942024

PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM by Pharmacia Deltec, Inc. — Product Code LJT

K942024 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 1994. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), 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
July 26, 1994
Date Received
April 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
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)
  • 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)
  • K932198 — PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH (May 2, 1994)
  • K932211 — PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS (May 2, 1994)
  • K932433 — PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE (May 2, 1994)
  • K932430 — DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER (May 2, 1994)

Other clearances for product code LJT

  • K260916 — FLEXI-PORT™ Power Injectable Implantable Port (June 17, 2026)
  • K252478 — Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Inj (September 5, 2025)
  • K251253 — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M. (June 18, 2025)
  • K242328 — PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implan (October 31, 2024)
  • K232737 — PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp (December 8, 2023)
  • K190559 — SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (May 22, 2020)
  • K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®) (July 8, 2019)
  • K151239 — NMI DUAL PORT II (June 6, 2016)
  • K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports (May 20, 2016)
  • K153238 — Dignity Dual Port (March 15, 2016)

FDA data resources