# K792007: CSF-Ventricular Catheter, Standard Des

- Pathway: 510(k) (Traditional)
- Applicant: Pudenz-Schulte Medical Research Corp.
- Decided: Jan 16, 1980 after 103 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K063836: Rivulet Ventricular and Snap Shunt and Convertible Ventricular Catheters, Models 41701 and 41704-41715 (2007), 0 descendants of its own

## Recalls of this device
- Jan 11, 2021 · Class II · Z-1117-2021: Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
- Nov 18, 2013 · Class II · Z-0397-2014: Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
- Feb 12, 2009 · Not classified · Z-1148-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1127-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1146-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1145-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1139-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1124-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1137-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1152-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1138-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1125-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1130-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1131-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1126-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1135-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1147-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1134-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1140-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1151-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1143-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1133-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1142-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1132-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1141-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1149-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1136-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1144-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1128-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1129-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
- Feb 12, 2009 · Not classified · Z-1150-2009: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

Source page: https://510kreport.com/device/K792007
Methodology: https://510kreport.com/methodology