Oscor Permanent Retractable Screw-In Pacing Lead Model PR

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

510(k) Number

K964107 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

PT

• Implant Pacing Lead Tined #3390, Modification

  Class III

  FDA 510(k) K913203 Active Cleared 23 Sep 1991

• Miscellaneous Pacing Lead

  Class II

  FDA 510(k) K925168 Active Cleared 3 May 1994

• Pacer Sensing Analyzer (Psa 100)

  Class II

  FDA 510(k) K882327 Active Cleared 6 Oct 1988

• Implant Pacemaker Lead, Tined

  Class III

  FDA 510(k) K913201 Active Cleared 23 Sep 1991

• Model Py...u Unipolar & Bipolar Pacing Lead

  Class III

  FDA 510(k) K870034 Active Cleared 3 Mar 1987

• Oscor Medical Model Tme 64S Bipolar Temp/Heart Wir

  Class II

  FDA 510(k) K850622 Active Cleared 10 Apr 1985

See all devices from Oscor Medical Corp. →

• What is the primary purpose of the Oscor Permanent Retractable Screw-In Pacing Lead Model PR and how is it implanted?

  The Oscor Permanent Retractable Screw-In Pacing Lead Model PR is designed for transvenous implantation in the heart to deliver reliable electrical pacing therapy. Its retractable screw-in fixation mechanism ensures stable positioning within the cardiac chamber, which is critical for consistent pacing stimulation during cardiac electrophysiology procedures.

• Is this device intended for single-use or can it be reused after sterilization?

  The Oscor Permanent Retractable Screw-In Pacing Lead Model PR is explicitly supplied sterile and intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.

• What storage and handling precautions should be taken for this device?

  Since the lead is sterile and single-use, it must be stored and handled according to standard sterile medical device protocols. This includes maintaining the packaging integrity until immediate use and adhering to manufacturer guidelines to prevent contamination or damage.

• Are there any known restrictions on using this device in patients who require MRI scans?

  The Oscor Permanent Retractable Screw-In Pacing Lead Model PR does not have any explicitly stated MRI compatibility restrictions in the provided data. However, MRI use with pacing leads generally requires careful consideration due to potential electromagnetic interference risks, so clinical judgment and institutional protocols should guide its application.

• How is this device regulated by the FDA, and what classification does it fall under?

  The Oscor Permanent Retractable Screw-In Pacing Lead Model PR is classified as a Class III medical device under FDA regulations and is subject to compliance with 21 CFR 870.3680. It was cleared via a 510(k) submission (Traditional pathway) and falls under the Cardiovascular (CV) Advisory Committee, with a decision of Substantially Equivalent and tracking requirements.