# K013005: Act 11 MP Ventricular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Innerspace, Inc.
- Decided: Mar 8, 2002 after 183 days
- Product code: HCA (Catheter, Ventricular)
- Device class: 2
- Regulation: 21 CFR 882.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002765 (2000). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010422: Act II Icp Monitoring System and Ventricular Catheter, Innerspace, Inc. (2001) Summary page 1.
- K002765: Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer Kits-IM,IM2,IM3,II1 Licoximc Tempe, Integra Neurosciences (2000) Summary page 1.

## 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

## Indications for use
The use of the ACT II MP Monitoring System by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in parenchyma is clinically important and when the patient may require CSF drainage in the course of their care or when data from a second parameter may be deemed useful in optimum patient management.

Source page: https://510kreport.com/device/K013005
Methodology: https://510kreport.com/methodology