# K081889: Rhapsody CT

- Pathway: 510(k) (Traditional)
- Applicant: Grantadler Corporation
- Decided: Nov 12, 2008 after 133 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). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 1.
- K043178: Grantalder Rhapsody Access Port and Catheter, Grantadler Corportation (2006) Summary page 1.

## Indications for use
The Grant Adler Rhapsody port line is intended to facilitate reliable and repeated acces of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products or the sampling of blood. Access is performed by percutaneous needle insertion, using only non-coring, Huber needles. When used with a power injectable needle, Rhapsody CT is indicated for power injection of contrast media. For power injection of contrast media, the maxum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle and 2 ml/s with 22 gauge non-coring power injectable needle. The Rhapsody CT has been tested and is conditionally safe to use in an MRI environment up to 3T. The Port is normally included in a Convenience Kit which will be used for the procedure. The GrantAdler Convenience Kit includes all cleared or exempt devices.

Source page: https://510kreport.com/device/K081889
Methodology: https://510kreport.com/methodology