Model EV4543 Miniature Temporary Cardiac Pacemaker

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K870323 ↗

FDA Product Code

DTE

Device Class

Class II

Regulation

21 CFR Part 870.3600

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Pace Medical →

• What clinical scenarios is the EV4543 temporary cardiac pacemaker designed to address?

  The EV4543 is specifically designed for short-term pacing support in patients experiencing myocardial infarction or temporary heart block, where the heart’s natural conduction system is temporarily impaired. It delivers controlled electrical impulses to help regulate heart rhythm until the underlying condition stabilizes or resolves.

• Is the EV4543 pacemaker a single-use device, or can it be reused after a procedure?

  The EV4543 is supplied as a reusable external unit, meaning it is intended for multiple uses in different patients. It includes an internal power source and is engineered for durability, with a battery rated for up to 800 hours of continuous operation, making it suitable for prolonged temporary pacing needs.

• What are the dimensions and power specifications of the EV4543, and how does this affect its portability?

  The device measures 12.7 cm in length, 6.6 cm in width, and 3.3 cm in height, making it compact enough for bedside use. It features a constant voltage output up to 12 volts and adjustable pacing rates, ensuring reliable performance while remaining portable for clinical environments where space may be limited.

• How does the EV4543’s regulatory pathway differ from other temporary pacemakers, and what does this imply for its use?

  The EV4543 was cleared via the FDA’s 510(k) process (K870323) under Traditional clearance, meaning it was deemed substantially equivalent to a legally marketed predicate device. This pathway implies it has undergone rigorous review by the FDA’s Cardiovascular Advisory Committee to ensure safety and effectiveness for temporary pacing in myocardial infarction or heart block cases, providing confidence in its clinical reliability.

• What battery life can clinicians expect from the EV4543, and how does this compare to other temporary pacing solutions?

  The EV4543’s internal battery is rated for up to 800 hours of continuous use, which is significantly longer than many other temporary pacing systems. This extended runtime reduces the need for frequent battery replacements or interruptions in pacing support, making it ideal for acute care settings where prolonged monitoring may be required.