# K981046: Medtronic PS Medical External Drainage and Monitoring (Edm) Ventricular Catheter, 20CM and 35 CM Model # 96115 and 96118

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic PS Medical
- Decided: Jun 16, 1998 after 88 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
Longest line of descent: 1 generation back to K902257 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902257: Codman* External Drainage System II (Eds-II), Codman & Shurtleff, Inc. (1990) Summary page 1.
- K910938: Codman External Drainage System II (Eds II), Codman & Shurtleff, Inc. (1991). Our OCR of the scanned summary read K920938, FDA’s number for VJW2919 Pneumatic Compression Upgrade (Varian Canada, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Codman External Drainage Catheter Set”.
- K951258: PS Medical Bioglide CSF-Flow Control Shunt Kit, Pudenz-Schulte Medical Research Corp. (1995) Summary page 1.

## Indications for use
The EDM Ventricular Catheters with BioGlide are designed for use as the proximal component for cerebrospinal fluid (CSF) drainage and/or monitoring from the lateral ventricles of the brain.

Source page: https://510kreport.com/device/K981046
Methodology: https://510kreport.com/methodology