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510(k) K994216

PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM by Sims Deltec, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2000
Date Received
December 15, 1999
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 Sims Deltec, Inc.

  • K010426 — PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CA (March 8, 2001)
  • K000842 — CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM (June 8, 2000)
  • K000942 — CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 (April 27, 2000)
  • K992697 — PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM (November 18, 1999)
  • K992880 — P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM (October 19, 1999)
  • K991599 — CADD ADMINISTRATION SET (June 15, 1999)
  • K991255 — CADD-TPN ADMINISTRATION SET, MODEL 21-7071 (June 9, 1999)
  • K991301 — CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPH (June 9, 1999)
  • K990083 — CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECU (February 12, 1999)
  • K984055 — CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS (January 29, 1999)

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  • 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)
  • K153228 — NMI Port, NMI Port II (December 4, 2015)