Isolation Sleeve Model 349-01

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790098 ↗

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 349-01 in a clinical setting?

  The Isolation Sleeve Model 349-01 is designed as a sterile, single-use barrier device to maintain aseptic conditions during the implantation of implantable pacemaker pulse generators. It acts as a protective enclosure to prevent contamination of the surgical field and the device itself while being handled, ensuring a cleaner procedural environment.

• Is the Isolation Sleeve Model 349-01 intended for reuse, or is it meant to be used only once?

  The Isolation Sleeve Model 349-01 is explicitly described as a single-use device. This design ensures sterility and reduces the risk of cross-contamination between patients, as it is intended to be discarded after one use.

• How is the Isolation Sleeve Model 349-01 supplied, and what should I expect in the packaging?

  The Isolation Sleeve Model 349-01 is supplied as a sterile, disposable item, ready for immediate use in the operating room. The packaging is designed to preserve its sterility until the moment of use, ensuring it remains uncontaminated during handling.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety standards?

  The Isolation Sleeve Model 349-01 received FDA 510(k) clearance (K790098) under the Traditional 510(k) pathway, with a decision of substantially equivalent to a predicate device. This means it was evaluated against existing, legally marketed devices to ensure it meets the same safety and performance standards, adhering to Class III medical device regulations—the highest regulatory classification for medical devices.

• Where would this device typically be used, and what type of surgical environment is it designed for?

  The Isolation Sleeve Model 349-01 is specifically designed for use in operating room environments where implantable pacemaker pulse generators are handled. It is intended to maintain aseptic conditions during the implantation procedure, ensuring the surgical field remains uncontaminated while the device is prepared and positioned.