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510(k) K945752

CELSITE(TM) BRACHIAL VENOUS PORT by B. Braun of America, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1995
Date Received
November 23, 1994
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 B. Braun of America, Inc.

  • K993024 — CELSITE IMPLANTABLE PORT WITH VALVED CATHETER (March 13, 2000)
  • K983794 — CHEMO MINI SPIKE PLUS (March 23, 1999)
  • K946170 — COMFORT-Q SUBCUTANEOUS INJECTION SETS (November 3, 1995)
  • K945850 — BRAUN DIACAN(R) FISTULA NEEDLES (October 6, 1995)
  • K942988 — FILTERED EXTENSION SETS (July 14, 1995)
  • K945551 — CELSITE(TM) DUAL VENOUS SYSTEM (April 21, 1995)
  • K943770 — LOW VOLUME MULTIPORT (April 10, 1995)
  • K950982 — B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE (April 4, 1995)
  • K950184 — B. BRAUN IV START KITS (March 15, 1995)
  • K943181 — DISPENSING PIN WITH ONE-WAY VALVE (September 29, 1994)

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)
  • 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)