Oscor Medical Fix Screw Pac Lead/Peel Cath, Modif

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

510(k) Number

K913205 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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 peelable cathode design in this pacemaker lead, and how does it benefit the surgical procedure?

  The peelable cathode design on the Fix Screw Pac Lead/ Peel Cath allows surgeons to precisely position the lead during implantation. This feature enables the removal of the outer protective sheath before final placement, ensuring accurate lead placement while maintaining sterility and reducing the risk of tissue damage during insertion.

• Is this device intended for reuse, or is it meant to be implanted permanently as a single-use item? How should it be handled to maintain sterility?

  This device is explicitly designed for single-use implantation only and is supplied sterile. To preserve sterility before use, it must be stored and handled according to standard sterile medical device protocols, ensuring the packaging remains intact until deployment in the operating room.

• What type of fixation mechanism does this pacemaker lead use, and why is this important for long-term reliability?

  The Fix Screw Pac Lead/ Peel Cath incorporates a screw mechanism for fixation within heart tissue. This design ensures stable electrical contact and secure anchoring, which is critical for reliable pacing therapy over the long term, reducing the risk of lead dislodgment or failure.

• What regulatory pathway was followed for this device, and which advisory committee reviewed its submission?

  This device was cleared through the FDA 510(k) pathway under the classification of Device Class III for permanent pacemaker electrodes. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, with a decision dated September 23, 1991, confirming it as substantially equivalent to predicate devices.