# K063377: Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 25, 2007 after 78 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 20 ancestors in all.
11 later devices descend from it; 8 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 3.

## Most influential descendants
- K072549: Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane Catheter (2007), 4 descendants of its own
- K072215: Titanium Powerport Isp Implanted Port (2007), 2 descendants of its own
- K251253: PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (2025), 1 descendant of its own
- K242328: PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports (2024), 1 descendant of its own
- K073423: Mri Powerport Implanted Port with 9.6 FR Silicone Catheter (2007), 1 descendant of its own

## Recalls of this device
- Feb 14, 2019 · Class II · Z-0582-2020: Complaints received that products packaged with the incorrect introducer sheath size.
- Jun 25, 2018 · Class II · Z-2080-2019: Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in 
- Feb 8, 2018 · Class II · Z-1766-2018: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- Feb 8, 2018 · Class II · Z-1761-2018: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- Feb 8, 2018 · Class II · Z-1767-2018: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- Feb 8, 2018 · Class II · Z-1772-2018: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- Feb 8, 2018 · Class II · Z-1760-2018: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

## Indications for use
The PowerPort TM Implanted Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the PowerLocTM 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/K063377
Methodology: https://510kreport.com/methodology