# K023015: Cardis

- Pathway: 510(k) (Traditional)
- Applicant: Schwarzer GmbH
- Decided: Sep 25, 2002 after 15 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K021137: Sanarus Centrica Core Tissue Biopsy System, Sanarus Medical, Inc. (2002). Our reading of the summary gave K021137, FDA’s number for Sanarus Centrica Core Tissue Biopsy System (Sanarus Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CATHCOR Desktop”. Kept off the family tree. Summary page 1.

## Indications for use
The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure, and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals. The Schwarzer cardis systems are intended for use in catheterization labs The Schwarzer cardis systems are indicated for use with patients of all ages under direct supervision of a physician or other trained health care professionals.

Source page: https://510kreport.com/device/K023015
Methodology: https://510kreport.com/methodology