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510(k) K131694

NMI PORT II CATHETER by Navilyst Medical, Inc. — Product Code LJT

K131694 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "NMI PORT II CATHETER". The FDA issued a decision of Substantially Equivalent on August 8, 2013. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Navilyst Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2013
Date Received
June 10, 2013
Clearance Type
Abbreviated
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 Navilyst Medical, Inc.

  • K163452 — PICC Maximal Barrier Nursing Kit (February 3, 2017)
  • K161866 — BioFlo Midline Catheter (September 8, 2016)
  • K151239 — NMI DUAL PORT II (June 6, 2016)
  • K153228 — NMI Port, NMI Port II (December 4, 2015)
  • K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage (September 24, 2015)
  • K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (September 24, 2015)
  • K150407 — BioFlo Midline Catheter (May 15, 2015)
  • K150527 — Xcela Power Injectable PICC (March 31, 2015)
  • K150448 — NMI PICC III and NMI PICC IV (March 19, 2015)
  • K142616 — PICC Maximal Barrier Nursing Kit (October 14, 2014)

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