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510(k) K130923

5F DIGNITY CT TITANIUM PORT by Medical Components, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2013
Date Received
April 3, 2013
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

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  • K123617 — 3F PRO-PICC (May 15, 2013)
  • K122423 — VASU-PICC (December 12, 2012)
  • K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT (September 21, 2012)
  • K120281 — DIGNITY POWER INJECTABLE TITANIUM PORT (September 17, 2012)

Other clearances for product code LJT

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  • 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)
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  • K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®) (July 8, 2019)
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  • K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports (May 20, 2016)
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  • K153228 — NMI Port, NMI Port II (December 4, 2015)