Intermedics Model 366-15 VS 1 Header Plug

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K920530 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Intermedics Model 366-15 VS 1 Header Plug in pacemaker systems?

  The Intermedics Model 366-15 VS 1 Header Plug is designed as a connector component for implantable pacemaker pulse generators. Its main function is to establish reliable electrical connectivity between the pulse generator and the associated leads, ensuring accurate signal transmission for cardiac pacing therapy.

• Is the Intermedics Model 366-15 VS 1 Header Plug intended for single-use or reusable applications?

  The device is explicitly labeled for single-use in a sterile setting, despite being a reusable connector component in its broader design. This means each unit should be discarded after one use to maintain sterility and compliance with medical device protocols.

• How is the Intermedics Model 366-15 VS 1 Header Plug regulated by the FDA, and what does that mean for its use?

  The device holds FDA 510(k) clearance (K920530) as substantially equivalent to a predicate device, classified under Class III (DXY) for implantable pacemaker systems. This means it meets FDA standards for safety and effectiveness in its intended role as a connector for pacemaker pulse generators, though it does not imply any specific clinical indication beyond its described function.

• What storage and handling precautions should be taken for the Intermedics Model 366-15 VS 1 Header Plug?

  Since the device is intended for single-use in a sterile setting, storage and handling must adhere to strict sterile medical device protocols. This includes maintaining proper packaging integrity, avoiding contamination, and following manufacturer guidelines to ensure sterility until use.