# K232737: 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

- Pathway: 510(k) (Special)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Dec 8, 2023 after 92 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122899: Powerport Clearvue Slim Implantable Port, C.R. Bard, Inc. (2012) Summary page 5.
- K063377: Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter, C.R. Bard, Inc. (2007) Summary page 5.
- K072549: Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane Catheter, C.R. Bard, Inc. (2007) Summary page 5.

## Indications for use
The PowerPort ™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the Powerloc ™ Safety Infusion Set, the PowerPort ™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

Source page: https://510kreport.com/device/K232737
Methodology: https://510kreport.com/methodology