Slimline Unipolar Endocardial Pacing Lead #30-401

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

510(k) Number

K853221 ↗

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. →

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

  The Slimline Unipolar Endocardial Pacing Lead (#30-401) is explicitly intended for single-use only. This is clearly stated in the device description, which emphasizes that it must be implanted in a controlled clinical setting while maintaining sterility. Reuse would violate sterility requirements and could compromise patient safety.

• What storage conditions are required to ensure the lead remains sterile before implantation?

  The device must be stored under conditions that preserve its sterility, though specific storage instructions (e.g., temperature, humidity, or packaging) are not detailed in the provided data. Since it is supplied sterile and intended for single-use, proper handling—such as keeping it in its original sealed packaging until use—is critical to maintaining its integrity.

• Can this lead be used in patients who require MRI scans, or does it pose any risks in an MRI environment?

  The device is not MRI-safe, as explicitly noted in the description. This means it should not be used in patients who require MRI imaging, as the magnetic fields could potentially interfere with the lead’s function or cause harm. Always verify compatibility with the patient’s imaging needs before implantation.

• What types of patients or clinical scenarios is this lead typically used for?

  This lead is designed for chronic cardiac pacing support, specifically for patients requiring endocardial pacing—a procedure where the lead is implanted inside the heart to regulate abnormal heart rhythms. It is not intended for temporary pacing or acute scenarios but rather for long-term use in patients with conditions like bradycardia or heart block.

• How do I confirm the regulatory status of this device before purchasing or using it?

  This lead holds FDA 510(k) clearance (K853221) under regulation 870.3680 and is classified as a Class III device. To confirm its current regulatory status, you can reference the FDA’s OpenFDA database using the k_number (K853221) or check the registration numbers listed (e.g., 2017865). Always verify with the manufacturer or FDA records before use to ensure compliance with the latest guidelines.