Polyflex 493-07 Endocardial Implantable Pac-Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854071 ↗

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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See all devices from Intermedics, Inc. →

• What is the Polyflex 493-07 Endocardial Implantable Pac-Lead used for in clinical practice?

  The Polyflex 493-07 is designed for endocardial implantation to deliver pacing stimuli directly to the heart, helping regulate abnormal heart rhythms in patients requiring cardiac pacing. It provides electrical stimulation to maintain proper heart function by contacting the inner lining of the heart chambers.

• Is this pacemaker lead intended for reuse, or is it meant to be used only once?

  This device is sterile upon supply and intended for single-use only. Due to its classification as a Class III medical device, it must be implanted in a sterile operating environment, which aligns with its non-reusable design to ensure patient safety and infection control.

• How is the Polyflex 493-07 compatible with MRI environments, and what does that mean for patients?

  The Polyflex 493-07 is specifically designed to be MRI-compatible, meaning it can be safely used in magnetic resonance imaging environments under the conditions outlined in its labeling. This allows patients with this pacemaker lead to undergo MRI scans when clinically necessary, provided they follow the manufacturer’s MRI safety guidelines.

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

  The Polyflex 493-07 received FDA 510(k) clearance through the Cardiovascular (CV) Advisory Committee under the Traditional 510(k) review pathway. It was determined to be substantially equivalent to a predicate device, meeting strict regulatory requirements for Class III permanent pacemaker electrodes (regulation 870.3680).