# K983331: Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic PS Medical
- Decided: Dec 16, 1998 after 85 days
- Product code: HCA (Catheter, Ventricular)
- Device class: 2
- Regulation: 21 CFR 882.4100
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940096 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940096: PS Medical Catheter Placement Kit, Pudenz-Schulte Medical Research Corp. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K951258: PS Medical Bioglide CSF-Flow Control Shunt Kit, Pudenz-Schulte Medical Research Corp. (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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.

## Indications for use
The Innervision Ventricular Catheter with BioGlide is designed to be used with the Neuropen endoscope or other compatible Medtronic PS Medical endoscope when the physician desires direct vision from the tip of a ventricular catheter during its placement. Direct vision facilitates placement of the catheter tip at a specific intraventricular location. The catheter is designed to be used as the proximal component of a CSF-Flow Control Shunt for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity.

Source page: https://510kreport.com/device/K983331
Methodology: https://510kreport.com/methodology