Isolation Sleeve Model 347-01

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790099 ↗

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 Isolation Sleeve Model 347-01 during pacemaker surgery?

  The Isolation Sleeve Model 347-01 is designed as a sterile, single-use barrier to maintain aseptic conditions during the implantation of implantable pacemaker pulse generators. It creates a protective enclosure around the device and surgical field to prevent contamination, ensuring sterile handling throughout the procedure.

• Is the Isolation Sleeve Model 347-01 reusable, or is it intended for single-use only?

  The Isolation Sleeve Model 347-01 is explicitly intended for single-use only. It is not designed for reuse or reprocessing, and must be discarded after a single procedure to maintain sterility and prevent contamination.

• How should the Isolation Sleeve Model 347-01 be stored before use?

  The sleeve must be stored in its original packaging until the time of use. This ensures sterility and integrity of the barrier until deployment in a sterile operating room environment.

• What regulatory pathway was followed for FDA clearance of the Isolation Sleeve Model 347-01?

  The Isolation Sleeve Model 347-01 received Traditional 510(k) clearance through the Cardiovascular Advisory Committee, with a decision of Substantially Equivalent (SESE). It is classified as a Class III medical device under FDA regulations (870.3610).