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Insulating Sheath

by Cordis Corp.

510(k) K801910

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801910 Date9 Sep 1980ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DXY
Device class
Class III
Regulation
21 CFR Part 870.3610
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Insulating Sheath 504605X is a medical device classified under the nomenclature for Implantable Pacemaker Pulse-Generator Components, specifically designed to provide electrical insulation for pacemaker leads. It serves as a protective barrier to prevent short circuits, ensure proper pacing functionality, and maintain the integrity of the pacing system during implantation and use.

This device is supplied as a single-use, sterile component intended for use in cardiovascular procedures. It is regulated under FDA 510(k) clearance (K801910) and falls under the product code DXY, adhering to regulatory standards for implantable cardiac devices. Storage and handling must comply with sterile medical device protocols to preserve its integrity before use.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Insulating Sheath 504605X in a pacemaker system?

    The Insulating Sheath 504605X acts as a protective barrier for pacemaker leads, preventing electrical short circuits and ensuring reliable pacing functionality. Its design maintains the integrity of the pacing system during both implantation and use, which is critical for safe and effective cardiac rhythm management.

  • Is the Insulating Sheath 504605X intended for reuse, or is it designed for single-use only?

    The Insulating Sheath 504605X is explicitly supplied as a single-use component. This classification aligns with sterile medical device protocols to preserve its integrity and prevent contamination, ensuring patient safety during cardiovascular procedures.

  • How should the Insulating Sheath 504605X be stored to maintain its sterility and functionality?

    Since it is a sterile, single-use device, storage must follow strict sterile medical device protocols. This includes keeping it in its original packaging, away from moisture, extreme temperatures, and direct sunlight, to preserve its integrity until use.

  • What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

    The Insulating Sheath 504605X received FDA 510(k) clearance (K801910) under the Traditional review pathway, with a Substantially Equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means it was deemed comparable to a legally marketed device in terms of safety and effectiveness for its intended use in pacemaker systems.