# K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached)

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: May 15, 2007 after 132 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
Longest line of descent: 7 generations back to K001901 (2000). 21 ancestors in all.
20 later devices descend from it; 8 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864349: Mediport II Single Lum/Port Implant Vasc Acs Port, C.R. Bard, Inc. (1987) Summary page 1.
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 1.

## Most influential descendants
- K091099: C-Port - HP Power Injectable Port (2009), 5 descendants of its own
- K072481: Jet Port Plus HP Catheter System (2008), 5 descendants of its own
- K071993: T-Port HP Infusion Port (2007), 5 descendants of its own
- K073210: Modification to: T-Port HP Infusion Port (2007), 4 descendants of its own
- K122767: Nmi Port (2013), 3 descendants of its own

## Recalls of this device
- Apr 12, 2012 · Not classified · Z-1626-2012: 50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
- Apr 2, 2012 · Class II · Z-1868-2012: Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
- Jul 2, 2010 · Not classified · Z-2235-2010: Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.

## Indications for use
THE POWER INJECTABLE IMPLANTABLE INFUSION PORT IS INDICATED FOR PATIENT THERAPIES REQUIRING REPEATED ACCESS TO THE VASCULAR SYSTEM. THE PORT SYSTEM CAN BE USED FOR INFUSION OF MEDICATIONS, LV. FLUIDS, PARENTERAL NUTRITION SOLUTIONS, BLOOD PRODUCTS AND FOR THE WITHDRAWAL OF BLOOD SAMPLES. WHEN USED WITH A POWER INJECTABLE NEEDLE, THE POWER INJECTABLE INFUSION PORT IS INDICATED FOR POWER INJECTION OF CONTRAST MEDIA. FOR POWER INJECTION OF CONTRAST MEDIA, THE MAXIMUM RECOMMENDED INFUSION RATE IS 5 ML/S WITH A 19 OR 20 GAUGE NON-CORING POWER INJECTABLE NEEDLE.

Source page: https://510kreport.com/device/K070003
Methodology: https://510kreport.com/methodology