Bipolar Sutureless Myocardial Pacing Leads

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K910528 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit

  Class II

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See all devices from Possis Medical, Inc. →

• Are these leads designed for both temporary and permanent cardiac pacing, or just one of them?

  These leads are explicitly designed for both temporary and permanent cardiac pacing applications. The description states they facilitate long-term ventricular pacing while also being suitable for temporary use, ensuring stable electrical connection to the heart muscle in either scenario.

• How are the leads supplied, and do I need to perform any additional preparation before use?

  The leads come pre-loaded onto a FasTac Introducer, which simplifies deployment. No additional preparation is required beyond attaching the introducer to the epicardial surface of the heart—sterility is maintained in the original packaging, so no further sterilization steps are needed.

• Are these leads reusable, or are they intended for single-use only?

  These leads are intended for single-use only, as explicitly stated in the device description. This aligns with standard practices for sterile medical devices to ensure patient safety and prevent cross-contamination.

• What regulatory pathway was followed for FDA clearance, and what does that mean for clinical use?

  The leads were cleared via an FDA 510(k) submission (K910528), classified under Class III standards (regulation number 870.3680). This means the device underwent a thorough review by the FDA’s Cardiovascular (CV) advisory committee to demonstrate substantial equivalence to a predicate device, ensuring safety and effectiveness for epicardial myocardial pacing and sensing.