# K874498: CSF-Ventriculostomy Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Pudenz-Schulte Medical Research Corp.
- Decided: Feb 11, 1988 after 101 days
- Product code: LKG (Port & Catheter, Implanted, Subcutaneous, Intraventricular)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K042198: PS Medical Neurosurgical Implants (2004), 0 descendants of its own

## Recalls of this device
- 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/K874498
Methodology: https://510kreport.com/methodology
