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510(k) K973862

PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS by Sims Deltec, Inc. — Product Code LJT

K973862 is an FDA 510(k) premarket notification submitted by Sims Deltec, Inc. for the device "PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 29, 1997. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Sims Deltec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1997
Date Received
October 9, 1997
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)
  • K994216 — PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM (January 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)
  • K991301 — CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPH (June 9, 1999)
  • K991255 — CADD-TPN ADMINISTRATION SET, MODEL 21-7071 (June 9, 1999)
  • K990083 — CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECU (February 12, 1999)

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