# K082126: Rhapsody Mri

- Pathway: 510(k) (Traditional)
- Applicant: Grantadler Corporation
- Decided: Nov 13, 2008 after 107 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: 2 generations back to K951814 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood.

Source page: https://510kreport.com/device/K082126
Methodology: https://510kreport.com/methodology