# K122899: Powerport Clearvue Slim Implantable Port

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 15, 2012 after 55 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 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) Titanium PowerPort® ISP with 5F Polyurethane Catheter: named in the summary without a submission number

## Most influential descendants
- K242328: PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports (2024), 1 descendant of its own
- K260916: FLEXI-PORT™ Power Injectable Implantable Port (2026), 0 descendants of its own
- 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 (2023), 0 descendants of its own
- K181446: Bard Power-Injectable Implantable Ports (PowerPorts®) (2019), 0 descendants of its own
- K150514: Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters (2015), 0 descendants of its own

## Recalls of this device
- Jan 15, 2020 · Class II · Z-1964-2020: The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
- 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-1768-2018: 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-1770-2018: 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-1763-2018: 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-1769-2018: 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-1765-2018: 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-1762-2018: 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-1773-2018: 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-1764-2018: 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-1771-2018: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

## Indications for use
The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter 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 (SIS), 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/K122899
Methodology: https://510kreport.com/methodology