# K013705: Act Iii Ventricular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innerspace, Inc.
- Decided: Sep 9, 2002 after 305 days
- Product code: GWM (Device, Monitoring, Intracranial Pressure)
- Device class: 2
- Regulation: 21 CFR 882.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Camino WNTRIXB True Tech Ventricular Tunneling Pressure Monitoring Kit NL960-V: named in the summary without a submission number

## Most influential descendants
- K041838: MPS (or MPS-T) (2005), 3 descendants of its own
- K072379: MPS Oxiport and MPS Oxiport Plus (2008), 2 descendants of its own
- K083378: Synergy (2009), 1 descendant of its own
- K161010: HICP200 Patient/Monitor Interconnect Cable (2016), 0 descendants of its own
- K113088: Hummingbird Subdural H900DS (Drainage and Icp), Hummingbird Subdural- H800S (Icp Only) (2012), 0 descendants of its own

## Indications for use
The use of a ACT 111 Ventricular Catheter by a qualified neurosurgeon is indicated when direct measurement of the intracranial pressure is clinically important and when the patient may require CSF drainage in the course of care.

Source page: https://510kreport.com/device/K013705
Methodology: https://510kreport.com/methodology