Model P In-Line Bipolar Endocardial Tined Lead

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

510(k) Number

K915188 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• Needle's Eye Snare

  Class II

  FDA 510(k) K961992 Active Cleared 27 Dec 1996

• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

  Class III

  FDA 510(k) K853590 Active Cleared 23 Oct 1985

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  FDA 510(k) K832255 Active Cleared 12 Aug 1983

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  FDA 510(k) K832893 Active Cleared 4 Oct 1983

• Model 325T Programmable Pulse Generator

  Class III

  FDA 510(k) K812358 Active Cleared 29 Oct 1981

See all devices from Cook Pacemaker Corp. →

• Is this lead designed for reuse in multiple patients, or is it intended for single-use only?

  This lead is explicitly stated as intended for single-use implantation in cardiovascular procedures. The regulatory data confirms it is supplied sterile and not designed for reuse, ensuring patient safety and sterility standards are maintained.

• What types of cardiac procedures is this lead typically used for, and where is it implanted?

  The Model P In-Line Bipolar Endocardial Tined Lead is designed for endocardial implantation within the heart, specifically for permanent pacemaker electrode applications. It is used in cardiovascular procedures to manage cardiac rhythm by providing precise sensing and pacing, with tines to secure stable fixation.

• How is the lead supplied, and what should clinicians consider regarding sterility?

  The lead is supplied sterile and packaged for single-use, ensuring it meets clinical sterility requirements for implantation. Clinicians should follow standard sterile technique protocols during handling and insertion to maintain integrity, as reuse is not permitted.

• What regulatory pathway was followed for this device’s approval, and what ongoing requirements apply?

  This lead received FDA 510(k) clearance under classification DTB (Permanent Pacemaker Electrode) and regulation 870.3680, with a Special Expert Panel (SESP) decision in 1992. Postmarket surveillance is required, meaning ongoing monitoring and reporting may apply to ensure continued safety and performance after approval.