Implantable End. Mush. Tip LEADS030-224

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

510(k) Number

K792321 ↗

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 the IMPLANTABLE END. MUSH. TIP LEADS 030-224 in a patient’s cardiac treatment plan?

  This device is designed as a permanent pacemaker electrode to deliver electrical stimulation to the heart, helping regulate rhythm in patients with bradycardia or conduction disorders. Its end-mush tip configuration ensures secure anchoring in cardiac tissue while reducing trauma during implantation, making it ideal for long-term pacing support.

• Is this lead intended for reuse, or is it meant for single-use only after implantation?

  The IMPLANTABLE END. MUSH. TIP LEADS 030-224 is supplied sterile and explicitly intended for single-use implantation. It is not designed for reuse, as single-use ensures patient safety and sterility standards are maintained.

• Where is this device typically implanted, and what type of facility would perform the procedure?

  This lead is intended for use within cardiac pacemaker systems and is implanted in the heart during procedures conducted in hospital operating rooms or electrophysiology labs. The procedure requires specialized equipment and trained personnel to ensure proper placement and function.

• What regulatory pathway does this device follow, and how does that affect its use?

  The IMPLANTABLE END. MUSH. TIP LEADS 030-224 follows the FDA 510(k) clearance pathway (K792321) and is classified as a Class III medical device, meaning it undergoes rigorous review to ensure safety and effectiveness. This classification reflects its critical role in life-sustaining or supporting cardiac function, requiring compliance with strict regulatory standards.

• Are there multiple sizes or models available for this lead, and if so, how would a clinician determine the appropriate one for a patient?

  The provided data does not specify individual sizes or models beyond the 030-224 designation, but the device is categorized under OpenFDA’s product codes (DTB) for permanent pacemaker electrodes. Clinicians would typically select the appropriate lead based on patient anatomy, pacing requirements, and compatibility with the implanted pacemaker system, often guided by manufacturer specifications or electrophysiologist recommendations.