# K011812: Spectrum Ventricular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Nov 8, 2001 after 150 days
- Product code: NHC (Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents))
- Device class: 2
- Regulation: 21 CFR 882.4100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
134 later devices descend from it; 3 cite it directly.
15 of 135 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) Cook Incorporated’s Ventricular Catheter: named in the summary without a submission number

## Most influential descendants
- K021557: Spectrum Silicone Catheter (2003), 126 descendants of its own
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line (2005), 119 descendants of its own
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter (2007), 66 descendants of its own
- K061179: Powerhickman Long-Term Intravascular Catheter (2006), 47 descendants of its own
- K091953: Pro-Picc (2009), 29 descendants of its own

## Recalls of this device
- May 31, 2018 · Class II · Z-2791-2018: This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndro

## Indications for use
The SPECTRUM® Ventricular Catheter is intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure of fluid volume. The device will be supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K011812
Methodology: https://510kreport.com/methodology