Model 366-14 Intermedics Lead Connector Cap

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864738 ↗

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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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

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  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 366-14 Intermedics Lead Connector Cap in a pacemaker system?

  The Model 366-14 Intermedics Lead Connector Cap is designed as a protective cap to ensure secure and insulated electrical continuity between a pacemaker lead and the pacemaker device. It prevents dislodgement or contamination during implantation or use, helping maintain the integrity of the connection in cardiovascular procedures.

• Is the Model 366-14 Intermedics Lead Connector Cap intended for reuse, or is it meant for single-use only?

  The device is explicitly intended for single-use in cardiovascular procedures. This ensures sterility and reduces the risk of contamination or infection, which is critical in implantable medical device applications.

• How is the Model 366-14 Intermedics Lead Connector Cap supplied, and what precautions should be taken during handling?

  The Model 366-14 is supplied sterile, meaning it is pre-sterilized and packaged to maintain sterility until use. Since it is intended for single-use, it must be handled using sterile technique in a controlled clinical environment to prevent contamination before and during implantation.

• What types of pacemaker lead systems is the Model 366-14 Intermedics Lead Connector Cap compatible with?

  The device is designed to be compatible with various pacemaker lead systems, though exact compatibility should be verified with the manufacturer’s guidelines or documentation for the specific leads being used. Its role is to provide a secure, insulated connection between the lead and the pacemaker.

• What regulatory pathway was followed for the commercial distribution of the Model 366-14 Intermedics Lead Connector Cap?

  The device underwent FDA 510(k) clearance through a traditional review process, with a decision of