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510(k) K880297

SEA - PORT INFUSION SET by Harbor Medical Devices, Inc. — Product Code LJT

K880297 is an FDA 510(k) premarket notification submitted by Harbor Medical Devices, Inc. for the device "SEA - PORT INFUSION SET". The FDA issued a decision of Substantially Equivalent on February 19, 1988. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Harbor Medical Devices, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1988
Date Received
January 25, 1988
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 Harbor Medical Devices, Inc.

  • K884628 — HARBORIN CENTRAL VENOUS CATHETER (May 15, 1989)
  • K890518 — SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM (April 21, 1989)
  • K882657 — HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT (December 13, 1988)
  • K881884 — HARBOR CENTRAL VENOUS CATHETER (July 28, 1988)
  • K882190 — S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM (June 9, 1988)
  • K874414 — HYPODERMIC NEEDLES, SINGLE LUMEN (January 14, 1988)

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