# K211375: Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Sep 10, 2021 after 129 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: 2 generations back to K913375 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081576: Blazer DX-20 Diagnostic Catheter, Boston Scientific Corp (2009) Summary page 4.

## Most influential descendants
- K232651: BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (2023), 0 descendants of its own

## Indications for use
The Blazer Dx-20 Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Source page: https://510kreport.com/device/K211375
Methodology: https://510kreport.com/methodology