Cleared Special

K232737 - PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port

Also marketed or referenced as:
PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port PowerPort™ Slim ECG Enabled Implantable Port

K232737 is an FDA 510(k) clearance for PowerPort ClearVUE Slim ECG Enabled Imp..., manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 92-day FDA review.

K232737 · Bard Peripheral Vascular, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
92d
Days
Class 2
Risk

K232737 is an FDA 510(k) clearance for the PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on December 8, 2023 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K232737

510(k) Number K232737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2023
Decision Date December 08, 2023
Days to Decision 92 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

LJT Device Classification - Class 2, Special Controls

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 287
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K232737.
Vaccess™ CT Low-Profile Power-Injectable Implantable Port
K252478 · Bard Access Systems, Inc. · Sep 2025
PowerPort™ 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
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
NMI DUAL PORT II
K151239 · Navilyst Medical, Inc. · Jun 2016
K232737 · PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port
Download PDF FDA Summary Bard Peripheral Vascu…