External Silastic Boot for Cardiac Pulse

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K801806 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• ArcoBiolith Pacemaker Model

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• Decubitus Mattress

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• Arcolith 3022&Arcolith 3023 Cardiac Gen.

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  FDA 510(k) K800838 Active Cleared 4 Jun 1980

• Pacemaker & Cardiac Lead, Bipolar

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  FDA 510(k) K771262 Active Cleared 21 Jul 1977

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• What is the primary purpose of the External Silastic Boot for Cardiac Pulse, and how does it integrate with existing pacemaker systems?

  The External Silastic Boot for Cardiac Pulse is designed to protect and isolate the pulse generator component of implantable pacemakers, acting as a barrier to reduce the risk of infection or mechanical damage. It is specifically engineered to fit over the pulse generator, ensuring compatibility with existing implantable pacemaker systems without requiring modifications to the underlying device.

• Is this device intended for single-use or reusable applications, and how does that affect its use in clinical settings?

  The External Silastic Boot for Cardiac Pulse is supplied as a reusable component, meaning it is intended to be used multiple times in cardiovascular procedures. This design allows for cost-effective use in clinical settings while maintaining the goal of protecting the pulse generator from contamination or damage during implant or follow-up procedures.

• What regulatory pathway was followed for this device, and what does that mean for its use in healthcare facilities?

  The External Silastic Boot for Cardiac Pulse underwent FDA 510(k) clearance (K801806) and is classified as a Class III device under 21 CFR 870.3610. This means it was reviewed by the FDA’s Cardiovascular (CV) advisory committee and determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets stringent safety and effectiveness standards for use in protecting implantable pacemaker pulse generators.

• How does the device’s compatibility with pacemaker systems ensure safety and reliability during procedures?

  The boot is explicitly designed to fit over the pulse generator of implantable pacemaker systems, ensuring a secure and snug barrier. This compatibility minimizes the risk of infection or mechanical damage during surgical procedures or follow-up care, while also maintaining the integrity of the pulse generator’s functionality. Its design aligns with existing systems without altering their core operation.