Endocardial Leads-Mod. to the Polyvinylpyrrolidone

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

510(k) Number

K910924 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascutek Vascular Prothesis VP1200K/50K

  Class II

  FDA 510(k) K830016 Active Cleared 21 Dec 1983

• Vivalith 5 - MDL-201A & TDL-201A

  Class III

  FDA 510(k) K801763 Active Cleared 27 Aug 1980

• Cardiovascular Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K891905 Active Cleared 5 Jun 1989

• Pacemaker Connector Plug

  Class II

  FDA 510(k) K821548 Active Cleared 2 Jun 1982

• Personal Medication Infuser

  Class II

  FDA 510(k) K830570 Active Cleared 24 Mar 1983

• Pacemaker Unipolar Adapter

  Class II

  FDA 510(k) K821547 Active Cleared 2 Jun 1982

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• What is the primary purpose of these endocardial leads with polyvinylpyrrolidone modification?

  These leads are designed as permanent pacemaker electrodes implanted within the heart to deliver electrical impulses to the endocardium (inner heart lining), regulating abnormal heart rhythms. The polyvinylpyrrolidone modification enhances biocompatibility and long-term stability, reducing the risk of adverse tissue reactions over time.

• Are these leads intended for reuse or single-use, and how should they be handled?

  The leads are supplied sterile and intended for single-use only. They must be handled following standard sterile medical device protocols to maintain integrity and prevent contamination before implantation.

• What sizes or models are available for these endocardial leads, and how are they categorized?

  The leads are categorized under FDA product code DTB and come in multiple model references listed in the OpenFDA records (e.g., 3002618605, 1028232). Exact sizing details would require referencing the manufacturer’s specifications, but they are tailored for endocardial pacing applications.

• Can these leads be used in patients who require MRI scans, or are there any restrictions?

  The device data does not mention MRI compatibility, so there are no explicit restrictions provided. However, clinicians should consult the manufacturer’s guidelines or device labeling for MRI safety information, as compatibility can vary by model and scan parameters.

• How were these leads determined to be substantially equivalent to prior devices, and what regulatory pathway was followed?

  The leads were classified as FDA Class III and granted a Traditional 510(k) clearance (K910924) under regulation 870.3680, with a decision of *Substantially Equivalent* (SESE). This pathway compares the device to legally marketed predecessors to demonstrate safety and effectiveness for permanent cardiac pacing applications.