Cleared Traditional

PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS

K973862 · Sims Deltec, Inc. · General Hospital
Dec 1997
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K973862 is an FDA 510(k) clearance for the PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS, a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II — Special Controls, product code LJT), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 29, 1997, 81 days after receiving the submission on October 9, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5965.

Submission Details

510(k) Number K973862 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 1997
Decision Date December 29, 1997
Days to Decision 81 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