Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K211375 ↗

FDA Product Code

DRF

FDA applicant

Boston Scientific Corporation

Device Class

Class II

Regulation

21 CFR Part 870.1220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary use of the Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter in clinical settings?

  The Blazer Dx-20 is designed specifically for electrophysiological studies, allowing clinicians to perform intracardiac stimulation (pacing) and precise recording of electrical potentials within the cardiovascular system. Its duodecapolar configuration (20 electrodes) enables detailed mapping and analysis of heart rhythms, which is essential for diagnosing arrhythmias and guiding ablation procedures.

• Is the Blazer Dx-20 catheter intended for single-use or reusable applications, and how does this affect its sterility?

  The Blazer Dx-20 is supplied as a single-use device and is non-sterile as indicated in the manufacturer’s documentation. This means it must be sterilized by the facility prior to use if reprocessing is attempted, though the manufacturer does not recommend reuse. Clinicians should follow standard medical device sterilization protocols if reprocessing is necessary, though single-use is the intended approach.

• What size and model variations are available for the Blazer Dx-20, and how does this impact its clinical application?

  The Blazer Dx-20 is currently available in a single size: 7 French (7F). This fixed size is optimized for precise navigation within the cardiovascular system, particularly for intracardiac recording and pacing during electrophysiological studies. The bidirectional steerability allows for flexible positioning, but the 7F diameter ensures compatibility with standard sheaths and access routes in electrophysiology labs.

• How should the Blazer Dx-20 catheter be stored, and are there any special handling considerations?

  While the device itself is non-sterile, storage should follow standard medical device protocols for diagnostic catheters to maintain its integrity. The manufacturer does not specify unique storage conditions beyond typical environmental controls (e.g., protected from moisture, extreme temperatures, or physical damage). Since it is single-use, it should be stored in a clean, dry environment until use, and any reprocessing (if attempted) must adhere to validated sterilization procedures.

• What regulatory pathway was followed for FDA clearance of the Blazer Dx-20, and what does this imply for clinicians?

  The Blazer Dx-20 received FDA 510(k) clearance (K211375) under the Traditional 510(k) pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This implies that the device was evaluated for safety and effectiveness against a previously cleared diagnostic catheter, ensuring compliance with FDA standards for electrophysiological tools. Clinicians can rely on this clearance as evidence of regulatory review for its intended use in electrophysiology labs.