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510(k) K942784

NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED by Norfolk Medical Products, Inc. — Product Code LJT

K942784 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED". The FDA issued a decision of Substantially Equivalent on May 2, 1995. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Norfolk Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1995
Date Received
June 14, 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 Norfolk Medical Products, Inc.

  • K192291 — TidalPort-AP Implantable Apheresis Vascular Access Port (August 20, 2020)
  • K112713 — NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS (October 27, 2011)
  • K102385 — NORFOLK MEDICAL NORPORT FAMILY OF PORTS (January 14, 2011)
  • K896544 — MD2 PERSONAL INFUSION SYSTEM (May 2, 1990)
  • K872838 — NORFOLK NORPORT (TM) -SP (SKIN PARALLEL) (August 25, 1987)
  • K871209 — NORFOLK MEDICAL NORPORT (June 24, 1987)
  • K871192 — SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT (June 10, 1987)
  • K870187 — NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT (May 7, 1987)
  • K870519 — SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT (April 15, 1987)
  • K870188 — NORFOLK MEDICAL BUTTERFLY INFUSION SET (February 10, 1987)

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