Silicone Rubber Isolation Sleeve 351-01

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833198 ↗

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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  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

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  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Silicone Rubber Isolation Sleeve 351-01 in an implantable pacemaker system?

  The Silicone Rubber Isolation Sleeve 351-01 acts as a protective barrier to isolate and electrically insulate components within an implantable pacemaker pulse generator. It prevents short circuits and contamination inside the device’s housing, ensuring reliable operation and patient safety in cardiovascular applications.

• Is the Silicone Rubber Isolation Sleeve 351-01 intended for single-use or can it be reused?

  The sleeve is explicitly described as a reusable component for implantable pacemaker pulse generators. Proper storage and handling are required to maintain its functionality and sterility over repeated use.

• How is the Silicone Rubber Isolation Sleeve 351-01 regulated, and what classification does it fall under?

  The sleeve is regulated under FDA 510(k) clearance (K833198) and classified as a Class III device under product code DXY. It was determined *substantially equivalent* to a predicate device and falls under the Cardiovascular advisory committee category.

• What storage and handling requirements apply to the Silicone Rubber Isolation Sleeve 351-01?

  Since it is reusable, the sleeve must be stored and handled in compliance with medical device sterility and packaging standards to ensure its protective properties remain intact. Proper cleaning and sterilization protocols are critical to prevent contamination and maintain performance.