Endocard Pacing Lead Long Length PL200

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K800349 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Disposable Patient Cable

  Class II

  FDA 510(k) K910645 Active Cleared 7 May 1991

• Permanent Endocard. Unipolar Tined Lead

  Class III

  FDA 510(k) K812905 Active Cleared 4 Feb 1982

• Cardiovascular Temp. Pacemaker Elec

  Class II

  FDA 510(k) K820003 Active Cleared 26 Mar 1982

• Permanent Endocardial Unipolar Tined Atrial Electrode

  Class III

  FDA 510(k) K812270 Active Cleared 16 Sep 1981

• Endocardial Screw-In Lead with Platinum Porous Tip

  Class III

  FDA 510(k) K852446 Active Cleared 17 Sep 1985

• Permanent & Temporary Pacemaker Electrode

  Class III

  FDA 510(k) K820262 Active Cleared 12 Mar 1982

See all devices from Diag Corp. →

• What is the primary use of the Endocard Pacing Lead Long Length PL200 in clinical practice?

  The Endocard Pacing Lead PL200 is designed to deliver electrical stimulation directly to the heart’s endocardium, helping regulate abnormal heart rhythms (bradycardia) or conduction disorders in patients requiring permanent pacing. It is intended for implantation during cardiac pacing procedures to ensure proper heart function.

• Is the Endocard Pacing Lead PL200 meant for single-use or can it be reused?

  The PL200 is explicitly supplied as a single-use device, meaning it is intended for one-time implantation and should not be reused. Reuse could compromise sterility and patient safety, so adherence to single-use guidelines is critical.

• How was the FDA clearance for this device determined, and what does that mean for clinicians?

  The PL200 received FDA 510(k) clearance under the traditional review pathway, with a decision date of September 14, 1977. This classification means it was deemed *substantially equivalent* to a legally marketed predicate device, ensuring it meets regulatory standards for permanent pacemaker electrodes (Class III). Clinicians can rely on its compliance with cardiovascular medical specialty standards.

• What storage or handling considerations should be followed for the PL200?

  While the provided data does not specify exact storage conditions, as a single-use, implanted medical device, the PL200 should be stored in a clean, dry environment protected from contamination or physical damage. Follow manufacturer guidelines (Diag Corp.) for packaging integrity and expiration dates to ensure sterility and functionality before use.