Implant Aid Splicing Crimp & Sleeve

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K813518 ↗

FDA Product Code

KFJ

Device Class

Class III

Regulation

21 CFR Part 870.3710

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

• Poly Flex Implantable Pacing Lead

  Class III

  FDA 510(k) K802294 Active Cleared 3 Apr 1985

See all devices from Intermedics, Inc. →

• What is the Implant Aid Splicing Crimp & Sleeve used for in a clinical setting?

  This device is specifically designed to securely join pacemaker lead wires during surgical procedures, ensuring both electrical continuity and mechanical stability. It is intended for use in cardiovascular applications where lead repair or replacement is necessary, such as during pacemaker implantation or revision.

• Is the Implant Aid Splicing Crimp & Sleeve intended for reuse or single-use?

  The Implant Aid Splicing Crimp & Sleeve is supplied as a sterile, single-use component. It is meant for one-time use in controlled clinical environments like operating rooms or catheterization labs, ensuring patient safety and sterility.

• Where and how should the Implant Aid Splicing Crimp & Sleeve be stored?

  Since it is a sterile, single-use device, it should be stored in its original packaging until ready for use. The packaging should be kept in a clean, dry environment, protected from contamination, and away from extreme temperatures or direct sunlight to maintain sterility and integrity.

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

  The Implant Aid Splicing Crimp & Sleeve received FDA 510(k) clearance (K813518) under a Traditional review pathway with Substantially Equivalent (SESE) status, granted on January 12, 1982. It was classified as a Class III medical device and reviewed by the Cardiovascular (CV) Advisory Committee. No third-party review was involved in this clearance.