Cleared Traditional

CELSITE(TM) DUAL VENOUS SYSTEM

K945551 · B. Braun of America, Inc. · General Hospital
Apr 1995
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K945551 is an FDA 510(k) clearance for the CELSITE(TM) DUAL VENOUS SYSTEM, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 21, 1995, 158 days after receiving the submission on November 14, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K945551 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1994
Decision Date April 21, 1995
Days to Decision 158 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5965

Similar Devices — LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 286
Vaccess? CT Low-Profile Power-Injectable Implantable Port; Vaccess? CT Power-Injectable Implantable Port; PowerPort? duo M.R.I. ? Implantable Port
K252478 · Bard Access Systems, Inc. · Sep 2025
PowerPort? isp Implantable Port; PowerPort? Slim Implantable Port; PowerPort? M.R.I. ? Implantable Port; PowerPort? M.R.I.? isp Implantable Port
K251253 · Bard Access Systems, Inc. · Jun 2025
PowerPort? ClearVUE? Slim Implantable Ports and PowerPort? ClearVUE? Slim Implantable Ports
K242328 · Bard Access Systems, Inc. · Oct 2024
PowerPort? ClearVUE? Slim ECG Enabled Implantable Port; PowerPort? ClearVUE? isp ECG Enabled Implantable Port; PowerPort? isp M.R.I.? ECG Enabled Implantable Port; PowerPort? Slim ECG Enabled Implantable Port
K232737 · Bard Peripheral Vascular, Inc. · Dec 2023
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
K190559 · AngioDynamics, Inc. · May 2020
Bard Power-Injectable Implantable Ports (PowerPorts?)
K181446 · C.R. Bard, Inc. · Jul 2019