# K171620: PiCCO Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pulsion Medical Systems SE
- Decided: Feb 21, 2018 after 264 days
- Product code: KRB (Probe, Thermodilution)
- Device class: 2
- Regulation: 21 CFR 870.1915
- 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 K072364 (2007). 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)
- K072364: Pulsion Pulsiocath Thermodilution Catheters & Accessories, Pulsion Medical Systems AG (2007) Summary page 4.

## Indications for use
PiCCO Catheters are used as accessories for thermodilution and arterial blood pressure measurement. PiCCO Catheters are indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

Source page: https://510kreport.com/device/K171620
Methodology: https://510kreport.com/methodology