# K974726: Subdural Drainage Catheter Kit, Subdural Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Implants, SA
- Decided: Mar 18, 1998 after 90 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis Straight Ventricular Catheter with oval holes: named in the summary without a submission number
- (no number) P.S. Medical Surgical Drain: named in the summary without a submission number
- (no number) Cordis Orbis Sigma® Valve: named in the summary without a submission number
- (no number) Cordis Polypropylene Burr Hole Reservoirs: named in the summary without a submission number
- (no number) Cordis Ventricular Antechamber: named in the summary without a submission number
- (no number) Cordis Right Angle Catheter Guide: named in the summary without a submission number
- (no number) Cordis CSF Reservoir: named in the summary without a submission number

## Indications for use
The Subdural Drainage Catheter Kit is intended for drainage of extraventricular fluid collections, such as hygromas and chronic hematomas, into an external drainage system (such as the Suction Reservoir or the EDS or IDS Systems from Elekta) or an implanted catheter communicating with an appropriate drainage site. The patient’s clinical pathology dictates whether the Subdural Drainage Catheter is connected to an internal or external drainage system.

Source page: https://510kreport.com/device/K974726
Methodology: https://510kreport.com/methodology