Heart Lead Butterfly Clamp

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

Full name

Lead, Heart, Butterfly Clamp

510(k) Number

K770416 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Arcolith 2000 Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K791715 Active Cleared 27 Sep 1979

• Unipolar Programmable Lithium Card. Gen.

  Class III

  FDA 510(k) K801241 Active Cleared 30 Jun 1980

• ArcoBiolith Pacemaker Model

  Class III

  FDA 510(k) K780776 Active Cleared 3 Oct 1978

• Decubitus Mattress

  Class I

  FDA 510(k) K760963 Active Cleared 18 Nov 1976

• Arcolith 3022&Arcolith 3023 Cardiac Gen.

  Class III

  FDA 510(k) K800838 Active Cleared 4 Jun 1980

• Pacemaker & Cardiac Lead, Bipolar

  Class III

  FDA 510(k) K771262 Active Cleared 21 Jul 1977

See all devices from Arco Medical Products Co. →

• What is the primary purpose of the Heart Lead Butterfly Clamp in cardiac procedures?

  The Heart Lead Butterfly Clamp is designed to securely fixate heart leads during pacemaker implantation. Its purpose is to prevent displacement of the electrode within cardiac tissue, ensuring stable and reliable electrical conduction for pacing therapy. This stability is critical for long-term pacemaker functionality.

• Is the Heart Lead Butterfly Clamp intended for reuse, or is it meant to be used only once?

  The Heart Lead Butterfly Clamp is explicitly supplied sterile and intended for single-use only. This ensures patient safety and sterility in cardiac catheterization laboratories or operating rooms, where contamination risks must be minimized.

• How should the Heart Lead Butterfly Clamp be stored before use to maintain its integrity?

  The device must be stored in a sealed, dry environment prior to use. This prevents moisture damage and contamination, which could compromise its sterility and functionality during implantation.

• What regulatory pathway was followed for FDA clearance of this device?

  The Heart Lead Butterfly Clamp underwent a Traditional 510(k) review process through the FDA’s Cardiovascular (CV) Advisory Committee. It was classified as a Class III device under regulation 870.3680 and received clearance under the Substantially Equivalent (SESE) determination, with the 510(k) number K770416.