Silicone Rubber Isolation Sleeve 350-01

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K833199 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  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

• Implantable Pulse Generator Pacemakers

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  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 350-01 during pacemaker implantation procedures?

  The Silicone Rubber Isolation Sleeve 350-01 is designed as a protective barrier to shield implantable pacemaker pulse generators from contamination and mechanical damage during handling or surgical implantation. It creates a sterile, non-reactive enclosure around the device to ensure its integrity before and during placement.

• Is the sleeve reusable, or is it intended for single-use only?

  The sleeve is explicitly intended for single-use applications. This design ensures sterility and prevents cross-contamination between patients, which is critical in cardiovascular surgical settings where infection control is paramount.

• How is the sleeve supplied, and what should clinicians expect when receiving a shipment?

  The sleeve is supplied sterile and packaged individually. Clinicians can expect each unit to be pre-sterilized and ready for immediate use, eliminating the need for additional sterilization steps before application on the pulse generator.

• Can this sleeve be used with any implantable pacemaker pulse generator, or are there specific compatibility considerations?

  While the sleeve is designed to be compatible with implantable pacemaker pulse generators in general, its use is specifically authorized under FDA 510(k) clearance for this purpose. Clinicians should verify compatibility with their specific device model, particularly if the pulse generator has unique dimensions or materials that could affect the sleeve’s fit or function.

• Does the sleeve meet any specific regulatory standards related to MRI safety?

  Yes, the sleeve is manufactured to comply with regulatory standards that ensure compatibility with MRI-safe environments when used as directed. This means it is designed to minimize interference or risks during MRI procedures, provided the sleeve itself is applied correctly and the pulse generator adheres to MRI-safe guidelines.