# K081576: Blazer DX-20 Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Feb 3, 2009 after 243 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 K913375 (1991). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940168: Diagnostic II Catheter, Ep Technologies, Inc. (1994) Summary page 1.
- K913375: Torque Tube Steerocath (TM), Ep Technologies, Inc. (1991) Summary page 1.

## Most influential descendants
- K211375: Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter (2021), 1 descendant of its own
- K232651: BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (2023), 0 descendants of its own
- K230503: Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K081576
Methodology: https://510kreport.com/methodology