#335-01 Silic Rub Isola Sleeve for Int #281-03 Siz

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

510(k) Number

K853034 ↗

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

  Class III

  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 Silic Rub Isola Sleeve, and how does it function within an implantable pacemaker system?

  The Silic Rub Isola Sleeve acts as a protective silicone rubber barrier specifically designed to isolate components of an implantable pacemaker pulse generator. Its main functions are to provide electrical insulation and mechanical stability, ensuring the device operates safely and reliably within the cardiovascular system. This helps prevent potential complications like electrical short circuits or mechanical failure.

• Is this device intended for reuse, or is it meant to be used only once during a procedure?

  The Silic Rub Isola Sleeve is explicitly supplied as a single-use component, meaning it is intended for use in one surgical procedure only. This aligns with standard sterile medical device protocols to maintain patient safety and prevent contamination.

• How should the Silic Rub Isola Sleeve be stored, and what precautions should be taken to ensure its integrity?

  Since it is a sterile medical device, the sleeve must be stored and handled according to sterile medical device protocols. This includes keeping it in its original packaging until use, protecting it from physical damage, and ensuring it remains uncontaminated. Proper storage conditions help preserve sterility and functionality before implantation.

• Can this device be used in patients who require MRI scans, and how does it address compatibility concerns?

  Yes, the Silic Rub Isola Sleeve is explicitly designed to be compatible with MRI settings, meaning it can be safely used in patients who require magnetic resonance imaging. This feature is particularly important for pacemaker patients, as MRI compatibility reduces the risk of interference or damage to the device during scans.

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

  The Silic Rub Isola Sleeve was authorized through the FDA 510(k) clearance process (K853034) under a Traditional 510(k) pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means the FDA determined it meets the same safety and effectiveness requirements as a previously approved comparable device, ensuring it adheres to strict regulatory standards for use in implantable pacemaker systems.