Isolation Sleeve Model 346-01

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790101 ↗

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 Isolation Sleeve, Model 346-01, in a cardiovascular procedure setting?

  The Isolation Sleeve, Model 346-01, is designed as a sterile, single-use barrier to maintain aseptic conditions during cardiovascular procedures. It specifically protects implantable pacemaker pulse-generator systems from external contamination during handling and implantation, ensuring a clean environment for the device.

• How should the Isolation Sleeve, Model 346-01, be stored to preserve its integrity and sterility?

  The device must be stored in its sealed package to protect it from moisture and physical damage. Adherence to the manufacturer’s guidelines for shelf life is also required to ensure sterility and functionality before use.

• Is the Isolation Sleeve, Model 346-01, reusable, or is it intended for single-use only?

  The Isolation Sleeve, Model 346-01, is explicitly designed for single-use only. Its sterile packaging and barrier function are intended to be used once per procedure to prevent contamination, making reuse unsafe and unnecessary.

• What regulatory pathway does the Isolation Sleeve, Model 346-01, follow, and what classification does it hold?

  The Isolation Sleeve, Model 346-01, is classified as a Class III medical device under FDA regulations and follows the 510(k) clearance pathway. It was granted clearance (K790101) in 1979 and is intended for use in controlled clinical settings like operating rooms or catheterization labs.

• Can this device be used with any implantable pacemaker pulse-generator system, or are there specific compatibility requirements?

  While the Isolation Sleeve, Model 346-01, is intended for use with implantable pacemaker pulse-generator systems, the exact compatibility depends on the manufacturer’s instructions for handling and implantation. Always verify the sleeve’s fit and design with the specific device being used to ensure proper isolation and sterility.