Slim Vent Unipo Pacing Lead Using PolyU 90A, 30-281

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

510(k) Number

K852915 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the Slim Vent Unipo Pacing Lead designed for and how does its slim profile benefit patients?

  The Slim Vent Unipo Pacing Lead is designed for cardiac pacing applications, specifically as a permanent pacemaker electrode. Its slim profile and vented design are engineered to facilitate easier placement and improved stability within the heart, reducing potential complications during implantation and ensuring reliable electrical conduction for pacing therapy.

• Is this device intended for single-use or can it be reused after implantation?

  This device is supplied sterile for single-use implantation only. Reuse is not recommended or supported, as it could compromise sterility and patient safety. Proper sterile handling and storage protocols must be followed to maintain device integrity before use.

• How should the Slim Vent Unipo Pacing Lead be stored to ensure it remains effective?

  The device must be stored according to sterile medical device protocols to preserve its integrity. Since it is supplied sterile for single-use, it should remain in its original packaging until immediately before implantation, protected from contamination, moisture, or physical damage.

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

  The Slim Vent Unipo Pacing Lead received FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to predicate devices. It is classified as a Class III medical device under FDA regulations, reflecting its role in life-sustaining or supporting cardiac pacing therapy.