# K201445: MultiCath, AcQRate Dx Fixed Curve Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Sep 2, 2021 after 458 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- 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 K992965 (1999). 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)
- K992965: Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085, Cordis Webster, Inc. (1999) Summary page 4.

## Indications for use
The catheter is indicated for electrophysiological mapping of cardiac structures in adult patients; i.e., stimulation and recording only.

Source page: https://510kreport.com/device/K201445
Methodology: https://510kreport.com/methodology