Implantable Electrode Lead, 030-270 Using Polyuret

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

510(k) Number

K851297 ↗

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 primary purpose of this implantable electrode lead, and how does it function in the body?

  This device is designed as a permanent pacemaker electrode lead to regulate heart rhythm in patients with bradycardia or conduction disorders. It delivers precise electrical impulses to stimulate the heart chambers, ensuring proper cardiac function by maintaining an appropriate heartbeat.

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

  The lead is explicitly supplied sterile and intended for single-use implantation within the cardiovascular system. Reuse is not recommended or supported by the manufacturer.

• What materials is the lead constructed from, and how does this affect its compatibility with pacemaker systems?

  The lead is constructed from polyurethane, which provides durability and flexibility for long-term cardiac support. This material ensures compatibility with pacemaker systems, allowing for reliable electrical conduction and stability over extended periods.

• How is this device regulated, and what does the FDA clearance status indicate?

  This device holds FDA 510(k) clearance (K851297), meaning it has been determined to be substantially equivalent to a legally marketed predicate device. The clearance falls under classification 3 (870.3680), indicating it is a high-risk medical device regulated under strict standards for safety and effectiveness.

• What model number identifies this specific lead, and does it come in multiple sizes?

  This lead is identified by the model number 030-270. While the provided data does not specify multiple sizes, the polyurethane construction and design suggest it is tailored for specific pacing applications, ensuring proper fit and function within the cardiovascular system.