Polyflex Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K802293 ↗

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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  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  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

See all devices from Intermedics, Inc. →

• What is the Polyflex Implantable Pacing Lead used for in clinical practice?

  The Polyflex Implantable Pacing Lead is designed to deliver electrical stimulation to the heart, helping to maintain proper cardiac rhythm. It is specifically intended for patients with bradycardia or conduction disorders who require chronic pacing support, functioning as an electrode connected to an external pacemaker to regulate heart rate.

• Is the Polyflex Implantable Pacing Lead intended for single-use or can it be reused?

  The Polyflex Implantable Pacing Lead is supplied sterile and explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.

• How should the Polyflex Implantable Pacing Lead be stored to maintain its integrity?

  The Polyflex Implantable Pacing Lead must be stored and handled according to sterile medical device protocols. This includes keeping it in its original packaging, protecting it from contamination, and adhering to manufacturer guidelines to preserve sterility and functionality before use.

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

  The Polyflex Implantable Pacing Lead received FDA 510(k) clearance (K802293) under the Traditional review pathway, with a decision of *Substantially Equivalent* (SESE). It was evaluated by the Cardiovascular (CV) Advisory Committee and classified as a Class III device under 21 CFR 870.3680, reflecting its role in life-sustaining or life-supporting cardiac applications.

• Are there multiple sizes or models of the Polyflex Implantable Pacing Lead available?

  The Polyflex Implantable Pacing Lead is listed with multiple FEI numbers (e.g., 3002618605, 2183787), which may correspond to different configurations or models. However, the exact specifications (e.g., lead length, electrode type, or tip design) are not detailed in the provided data. For precise sizing or model selection, refer to the manufacturer’s catalog or technical documentation.