Model 352-01 Silicone Rubber Isolation Sleeve

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K863418 ↗

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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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 352-01 Silicone Rubber Isolation Sleeve in clinical settings?

  The Model 352-01 Silicone Rubber Isolation Sleeve acts as a protective barrier specifically designed to isolate and shield implantable pacemaker pulse generators from external interference and contamination. Its flexible silicone rubber construction ensures device integrity during and after implantation, helping maintain reliability in cardiovascular applications.

• Is the Model 352-01 Silicone Rubber Isolation Sleeve intended for reuse, or is it meant for single-use only?

  The Model 352-01 is explicitly supplied as a single-use device. This design ensures sterility and reduces the risk of cross-contamination, aligning with best practices for implantable medical devices.

• How is the Model 352-01 Silicone Rubber Isolation Sleeve packaged and prepared for clinical use?

  The sleeve is supplied in a sterile package, ready for immediate clinical use. The sterile packaging ensures it meets regulatory standards for cleanliness before implantation, minimizing infection risks.

• What regulatory pathway does the Model 352-01 Silicone Rubber Isolation Sleeve follow, and what does that mean for its use?

  The device was cleared via an FDA 510(k) submission (K863418) under the Traditional pathway, classified as a Class III medical device. This clearance confirms it adheres to strict safety and effectiveness standards for use with implantable pacemaker pulse generators in cardiovascular applications.

• What material is the Model 352-01 Silicone Rubber Isolation Sleeve made from, and why is this important?

  The sleeve is manufactured from silicone rubber, a biocompatible material chosen for its flexibility, durability, and resistance to bodily fluids. This ensures compatibility with implantable pacemaker pulse generators while providing a protective barrier against external factors like moisture or mechanical stress.