Sorin Pulse Generator, Model LIT-214

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

510(k) Number

K801640 ↗

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 Bentley Laboratories, Inc. →

• What is the primary purpose of the Sorin Pulse Generator, Model LIT-214, and who should use it?

  The Sorin Pulse Generator, Model LIT-214, is designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients with abnormal heart rhythms or conduction disorders who require cardiac pacing. This device is meant for use in clinical settings by trained healthcare professionals, such as cardiologists or electrophysiologists, during implant procedures.

• Is the Sorin Pulse Generator, Model LIT-214, a single-use or reusable device?

  The Sorin Pulse Generator, Model LIT-214, is explicitly described as a reusable implantable component. It is intended for repeated use in patients after initial implantation, provided it remains functional and adheres to proper maintenance and handling protocols.

• How is the Sorin Pulse Generator, Model LIT-214, regulated, and what does that mean for its use?

  The Sorin Pulse Generator, Model LIT-214, is classified as a Class III medical device under FDA regulations and has received FDA 510(k) clearance (K801640). This means it has been determined to be substantially equivalent to a legally marketed device and is regulated under product code DXY (Implantable Pacemaker Pulse-Generator). Its regulatory pathway ensures compliance with strict safety and performance standards for implantable cardiac devices.

• What storage and handling guidelines should be followed for the Sorin Pulse Generator, Model LIT-214?

  While the data does not specify sterility requirements, the Sorin Pulse Generator, Model LIT-214, is an implantable device, so it must be handled according to standard implantable device protocols to maintain functionality and patient safety. This includes proper storage conditions (e.g., clean, dry environment, protection from electromagnetic interference) and adherence to manufacturer guidelines for preparation before use.

• Does the Sorin Pulse Generator, Model LIT-214, have any known compatibility with MRI procedures?

  The provided data does not mention MRI safety for the Sorin Pulse Generator, Model LIT-214. If MRI exposure is required for a patient with this device, clinicians must consult the manufacturer’s latest labeling or guidelines to assess potential risks, as implantable pacemakers generally carry restrictions or precautions for MRI use.