510(k) · Cleared
Recalled · 2009Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic PS Medical · HCA Catheter, Ventricular
Cleared on Dec 16, 1998 as substantially equivalent to K940096 (Pudenz-Schulte Medical Research Corp., 1994) after an 85-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 29 times.
- Decided
- Dec 16, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- HCA
- Recalls
- 29
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940096 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK940096 PS Medical Catheter Placement KitPudenz-Schulte Medical Research Corp. · 1994
- This deviceK983331 Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model…Medtronic PS Medical · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940096 | PS Medical Catheter Placement Kit | Pudenz-Schulte Medical Research Corp. | 1994 | — |
| 0 (this device) | K983331 | Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102 | Medtronic PS Medical | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HCA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940096 | PS Medical Catheter Placement KitSummary page 1…4100) Predicate Device ldentification: Medtronic PS Medical Innervision Ventricular Catheter submitted under the Premarket Notification for the Catheter Placement Kit (K940096), Medtronic PS Medical Ventricular Catheter with BioGlide submitted under the Premarket Notification for the BioGlide Shunt Kit (… | 1994 |
| Kept off the family tree | K951258 | FDA’s K951258 is PS Medical Bioglide CSF-Flow Control Shunt Kit Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2009 | Not classified | Z-1148-2009 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
The 5 latest of 29 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HCA devicesHCA Catheter, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCA
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · HCA
Too few HCA 510(k)s in any year since 2007 to give a median.
Recalls per year · HCA
No recall names HCA since 2007.
Adverse event reports per year · HCA
1in 2021
MAUDE reports naming product code HCA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983331: Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983331
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026