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Biotronik Stylets

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191469

by Biotronik, Inc.

Identifiers

510(k) Number
K191469 FDA 510(k)
FDA Product Code
DRB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1380 FDA 510(k)
Regulation Number
870.1380 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Biotronik Stylets are manual surgical instruments classified as a stylet and catheter (product code DRB), designed for use during cardiovascular procedures. These devices assist in the implantation of pacemaker or implantable cardioverter-defibrillator (ICD) leads by providing structural support and guidance during insertion. Constructed from metal wire, they vary in stiffness and length to accommodate different clinical scenarios.

Biotronik Stylets are single-use devices regulated under FDA 510(k) clearance (K191469) and classified as Class II under special controls. They are intended for sterile use in surgical environments and are not MRI-compatible. Supplied in sterile packaging, these devices are intended for use in conjunction with pacemaker or ICD leads, adhering to manufacturer guidelines for proper handling.

Biotronik Stylets

Frequently asked questions

What is the primary purpose of the Biotronik Stylets?

The Biotronik Stylets are designed to assist in the implantation of pacemaker or implantable cardioverter-defibrillator (ICD) leads during cardiovascular procedures. They offer structural support and guidance to ensure accurate and stable lead placement within the heart, reducing the risk of misalignment or damage during insertion.

Are the Biotronik Stylets single-use or reusable?

The Biotronik Stylets are explicitly labeled as single-use devices. This classification ensures sterility and safety for each procedure, as reuse could compromise the device’s integrity and introduce infection risks. Always follow manufacturer guidelines for proper handling and disposal after a single use.

What materials are the Biotronik Stylets made from, and how does this affect their use?

The Biotronik Stylets are constructed from metal wire, which provides the necessary stiffness and flexibility to accommodate different clinical scenarios during lead implantation. The material choice ensures durability and precision during insertion while maintaining compatibility with pacemaker and ICD leads as specified by the manufacturer.

How are the Biotronik Stylets supplied, and what should clinicians consider during storage?

The Biotronik Stylets are supplied in sterile packaging, ensuring readiness for immediate use in surgical environments. Clinicians should store them in a clean, dry place away from direct sunlight or extreme temperatures to preserve sterility and integrity. Always check the packaging for signs of damage before use, and adhere to expiration dates to maintain efficacy.

Are there different sizes or models of Biotronik Stylets, and how do they vary?

The Biotronik Stylets come in varying lengths and stiffness levels to suit different anatomical and procedural requirements. These variations allow clinicians to select the appropriate stylet based on the specific lead type, patient anatomy, and insertion pathway. The manufacturer provides detailed specifications to guide selection, ensuring optimal performance for each use case.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Biotronik Stylets (K191469) — FDA 510 (k) | Innolitics, K191469 - Biotronik Stylets - Cardiovascular

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K191469 24 fields · synced Oct 1, 2026