# K110407: Invisiport

- Pathway: 510(k) (Traditional)
- Applicant: Stealth Therapeutics, Incorporated
- Decided: Oct 13, 2011 after 241 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: 7 generations back to K001901 (2000). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043178: Grantalder Rhapsody Access Port and Catheter, Grantadler Corportation (2006) Summary page 1.
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 2.
- K060036: Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access Systems with Dual Layer Catheter, Smiths Medical MD, Inc. (2006) Summary page 1.
- K934518: Strato Medical Infuse-a-Port/Infuse-a-Kit Periport Peripheral Access System, Strato Medical Corp. (1995) Summary page 1.

## Most influential descendants
- K141146: Invisiport (2015), 0 descendants of its own

## Indications for use
The Invisiport™ is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.

Source page: https://510kreport.com/device/K110407
Methodology: https://510kreport.com/methodology