# K091099: C-Port - HP Power Injectable Port

- Pathway: 510(k) (Traditional)
- Applicant: Phs Medical GmbH
- Decided: May 22, 2009 after 36 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: 8 generations back to K001901 (2000). 24 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030636: C-PORT, Clinisurg Vascular Products, LLC (2003) Summary page 2.
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 2.
- K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached), Medcomp (2007) Summary page 2.

## Most influential descendants
- K102385: Norfolk Medical Norport Family of Ports (2011), 3 descendants of its own
- K111101: Norport CT-PC, Lucent Non-Coring Needel Infusion Set (2011), 2 descendants of its own
- K112713: Norfolk Medical-Sportport-Family of Ports (2011), 1 descendant of its own
- K192291: TidalPort-AP Implantable Apheresis Vascular Access Port (2020), 0 descendants of its own
- K120281: Dignity Power Injectable Titanium Port (2012), 0 descendants of its own

## Indications for use
The C-Port' P "Power Injectable" Port (family of products) will be used as a subcutaneously Implanted device where repeated access to the vascular system is the therapy of choice for delivery of medications, fluids, special fluids such as contrast enhancement fluids or for withdrawal of blood. When used with a power injectable needle infusion set, the C-Port' "Power Injectable" Port is indicated for power injection of contrast media using an 8.OFr or 9.6Fr catheter. For power injection of contrast media, the maximum recommended Infusion rate is 5 mils with a 19 or 20 gauge non-coring power injectable needle or 2 mils with a 22 gauge non-coring power injectable needle. The C-Port p "Power Injectable" Port (family of products) will be used as a subcutaneously Implanted device where repeated access to the vascular system is the therapy of choice for delivery of medications, fluids, special fluids such as contrast enhancement fluids or for withdrawal of blood. When used with a power injectable needle Infusion set, the C-Port" "Power Injectable" Port is indicated for power injection of contrast media using an 8.0Fr or 9.6Fr catheter. For power Injection of contrast media, the maximum recommended infusion rate Is 5 mlls with a 19 or 20 gauge non-coring power Injectable needle or 2 ml/s with a 22 gauge non-coring power injectable needle. For CT diagnostic procedures, it is recommended that the number of CT "power injections" be limited to a maximum number of ten (10) accesses over the life of the device.

Source page: https://510kreport.com/device/K091099
Methodology: https://510kreport.com/methodology