# K111101: Norport CT-PC, Lucent Non-Coring Needel Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Norfolk Medical
- Decided: Aug 25, 2011 after 127 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: 11 generations back to K001901 (2000). 60 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102385: Norfolk Medical Norport Family of Ports, Norfolk Medical Products, Inc. (2011) Summary page 3.
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 2.
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle, Smiths Medical MD, Inc. (2007) Summary page 2.
- K081472: Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports, AngioDynamics, Inc. (2008) Summary page 2.
- K091099: C-Port - HP Power Injectable Port, Phs Medical GmbH (2009) Summary page 2.
- K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached), Medcomp (2007) Summary page 2.
- K072375: Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set, AngioDynamics, Inc. (2007) Summary page 3.
- K082306: Powerloc Clear Safety Infusion Set, C.R. Bard, Inc. (2008) Summary page 3.
- K080544: Unassigned, Medcomp (2008) Summary page 3.

## Most influential descendants
- 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

## Indications for use
The Lucent Non-coring needle set is intended for the administration of fluids and drugs as well as blood sampling through implanted vascular ports. When used with the NorPort CT-PC Family of Implanted Vascular Access Device is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 mI/s with a 19 and 20 gauge non-coring power injectable needle and 2 mI/s with a 22-gauge non-coring power injectable needle. The NorPort CT-PC Family of Implanted Vascular Access Devices is indicated for use when the patient requires the following: repeated access to the vascular system for injections, infusion of drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen. When used with a appropriately labeled power injectable needle infusion set, the NorPort CT-PC Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mI/s with a 19 and 20 gauge non-coring power injectable needle and 2 mI/s with a 22-gauge non-coring power injectable needle.

Source page: https://510kreport.com/device/K111101
Methodology: https://510kreport.com/methodology