Trios-M VS-1 Pulse Generator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K863878 ↗

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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• Pulse Generator

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• What is the Trios-M VS-1 Pulse Generator used for in clinical practice?

  The Trios-M VS-1 Pulse Generator is designed to deliver electrical impulses for regulating cardiac rhythm in patients with bradycardia or conduction disorders. It helps maintain a normal heartbeat by stimulating the heart when its natural electrical signals are insufficient, ensuring proper cardiac function and preventing complications from slow heart rates.

• Is the Trios-M VS-1 Pulse Generator intended for reuse or single-use, and how should it be handled before implantation?

  The Trios-M VS-1 Pulse Generator is intended for single-use only after surgical implantation. It is supplied sterile, so it must be handled with extreme care to avoid contamination before use. Proper aseptic techniques are required to maintain sterility until implantation by a qualified healthcare professional.

• What storage and handling precautions should be taken with the Trios-M VS-1 Pulse Generator?

  The device must be stored according to the instructions provided in its packaging to preserve sterility and functionality. Since it is not MRI-safe, it should be kept away from magnetic fields. Additionally, it should be handled carefully to prevent damage or contamination before use, as it is intended for one-time surgical implantation.

• How was the regulatory pathway for the Trios-M VS-1 Pulse Generator determined, and what does that mean for its use?

  The Trios-M VS-1 Pulse Generator was classified as a Class III device under FDA regulations due to its role in sustaining life or preventing significant health deterioration. It received FDA 510(k) clearance (K863878) as substantially equivalent to a predicate device, meaning it underwent a review to confirm it meets the same safety and effectiveness standards as an existing approved device. This clearance allows its use in clinical settings for its intended purpose.

• Can the Trios-M VS-1 Pulse Generator be used in patients who require MRI scans?

  No, the Trios-M VS-1 Pulse Generator is not MRI-safe, meaning it should not be exposed to magnetic resonance imaging (MRI) environments. MRI scans can interfere with the device’s function or cause harm to the patient, so alternative imaging methods must be used when necessary.