Lead Adapters #’s 6016, 6022, 6017, etc.

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

510(k) Number

K831160 ↗

FDA Product Code

DTD

Device Class

Class II

Regulation

21 CFR Part 870.3620

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• Are these Lead Adapters designed for single-use or can they be reused after proper cleaning and sterilization?

  These Lead Adapters are not single-use. The regulatory records explicitly state they are reusable components intended for use in sterile operating environments during cardiac implant procedures. They must be thoroughly cleaned and sterilized between uses to ensure safety and functionality, as outlined in the device description.

• What types of cardiac conditions are these Lead Adapters intended to support in patients?

  These Lead Adapters are designed to facilitate reliable pacing therapy for patients with bradycardia or conduction disorders, ensuring proper electrical continuity and mechanical stability within cardiac rhythm management systems. They connect pacemaker leads to implantable pulse generators, enabling effective pacing support.

• How are these Lead Adapters regulated, and what does that mean for their use in clinical settings?

  These Lead Adapters are regulated under FDA 510(k) clearance (K831160) and classified as Class II medical devices under product code DTD. The clearance indicates they are deemed substantially equivalent to a predicate device, meaning they meet established safety and performance standards for pacemaker lead adaptors. Clinically, this means they are subject to routine quality control, sterilization protocols, and adherence to cardiovascular best practices.

• What specific sizes or models (e.g., 6016, 6022) are available, and how do they differ?

  The Lead Adapters come in multiple models, including 6016, 6022, 6017, etc., though the exact differences between these variants (e.g., connector types, lead compatibility, or mechanical design) are not detailed in the provided data. These models are designed to accommodate various pacemaker lead types, ensuring compatibility with implantable pulse generators for reliable pacing therapy. For precise sizing or model-specific use cases, consult the manufacturer’s technical documentation.

• Are there any special handling or storage requirements for these reusable Lead Adapters?

  While the data does not specify exact storage conditions, reusable medical devices like these Lead Adapters typically require clean, dry environments to prevent contamination or damage. After use, they must undergo thorough cleaning and sterilization before reuse, as per standard operating procedures for reusable cardiovascular devices. Always follow the manufacturer’s instructions for maintenance and storage to ensure longevity and sterility.