Cardiovascular Temp. Pacemaker Elec

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K820003 ↗

FDA Product Code

LDF

Device Class

Class II

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

• Endocard Pacing Lead Long Length PL200

  Class III

  FDA 510(k) K800349 Active Cleared 28 May 1980

• 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

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• What is the CARDIOVASCULAR TEMP. PACEMAKER ELEC used for?

  This device is a temporary pacemaker electrode used in cardiovascular applications to deliver electrical impulses for temporary cardiac pacing, as indicated by its classification under the Cardiovascular medical specialty and product code LDF.

• How is the CARDIOVASCULAR TEMP. PACEMAKER ELEC supplied and is it reusable?

  The device is supplied as a single-use electrode for temporary pacemaker systems; while the data does not explicitly state sterility or reuse, its classification as a temporary cardiovascular electrode implies single-use application in clinical settings to prevent cross-contamination.

• What regulatory pathway was used for the CARDIOVASCULAR TEMP. PACEMAKER ELEC?

  The device received FDA 510(k) clearance on March 26, 1982, under K-number K820003, demonstrating substantial equivalence to a predicate device under regulation number 870.3680 and product code LDF.