# K090512: Powerport Duo M.R.I. Implanted Port with 9.5 FR. Dual Lumen Chronoflex Polyurethane Catheter

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 27, 2009 after 29 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PowerPort M.R.I. Implanted Port with 8.0 Fr. ChronoFlex Polyurethane Catheter: named in the summary without a submission number
- (no number) X-Port duo Implanted Port with 9.5 Fr. Dual Lumen (D/L) ChronoFlex Polyurethane Catheter: named in the summary without a submission number

## Most influential descendants
- K252478: Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port (2025), 0 descendants of its own
- K181446: Bard Power-Injectable Implantable Ports (PowerPorts®) (2019), 0 descendants of its own
- K153238: Dignity Dual Port (2016), 0 descendants of its own

## Recalls of this device
- Mar 25, 2021 · Class II · Z-1550-2021: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
- Mar 25, 2021 · Class II · Z-1551-2021: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
- Mar 25, 2021 · Class II · Z-1552-2021: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.

## Indications for use
The PowerPort' 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 a 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/K090512
Methodology: https://510kreport.com/methodology