Tendril Unipolar Endocardial Screw-In Lead

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

510(k) Number

K951087 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

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See all devices from Pacesetter, Inc. →

• What is the primary purpose of the Tendril Unipolar Endocardial Screw-In Lead, and how does it function in the body?

  The Tendril Unipolar Endocardial Screw-In Lead is designed for permanent implantation within the heart to deliver unipolar pacing stimulation. It fixes endocardially (inside the heart chambers) and provides electrical impulses to regulate cardiac rhythm in patients requiring chronic pacing support, such as those with bradycardia or conduction system disorders.

• Is this device intended for reuse, or is it meant to be used only once after implantation?

  The Tendril Unipolar Endocardial Screw-In Lead is explicitly intended for single-use implantation only. It is not designed for reuse, as its sterile packaging and endocardial fixation mechanism are optimized for one-time surgical use.

• How is the Tendril Lead supplied, and what should clinicians verify before use?

  The device is supplied sterile in its original packaging, ensuring it is ready for immediate use in cardiovascular procedures. Clinicians should verify the sterility seal and expiration date before opening, as well as confirm compatibility with the patient’s pacing system and implantation site.

• What regulatory pathway was used for FDA clearance of this device, and what does that mean for tracking?

  The Tendril Lead was cleared via the FDA 510(k) pathway (K951087) under the DTB product code, with a decision of *Substantially Equivalent – Subject to Tracking*. This means it is classified as a Class III device (regulation 870.3680) and must comply with FDA tracking requirements, including serial number registration for traceability.