Fix Screw Pacing Lead/Peelable Cath

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

Full name

Oscor Medical Fix Screw Pacing Lead/Peelable Cath

510(k) Number

K861493 ↗

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 catheter feature on this pacing lead, and how does it benefit the clinician during implantation?

  The peelable catheter feature on the OSCOR MEDICAL FIX SCREW PACING LEAD simplifies handling and positioning during implantation. It allows clinicians to peel away the catheter once the lead is properly placed, reducing the risk of snagging or dislodging the lead while minimizing the complexity of the procedure. This design enhances precision and control during the critical steps of securing the lead within heart tissue.

• Is this device intended for reuse, or is it designed for single-use only? How does this affect its sterility and clinical use?

  This device is explicitly designed for single-use only, as stated in the manufacturer’s description. It is supplied sterile in its packaging, ensuring a clean and uncontaminated state for immediate clinical use. Single-use design eliminates the need for reprocessing, reducing the risk of infection or device degradation between patients, which is critical for cardiac pacing procedures.

• What types of cardiac pacing systems is this lead compatible with, and how should it be stored before use?

  While the exact compatible pacing systems aren’t detailed, the lead is designed for use with standard cardiac pacing systems as indicated in the description. For storage, it should be kept in its sterile packaging until ready for use, following the manufacturer’s instructions to maintain integrity. Avoid exposure to extreme temperatures, moisture, or physical damage, as these could compromise sterility or functionality.

• How does the screw mechanism on this lead contribute to its stability in the heart tissue, and what clinical scenarios might benefit from this design?

  The screw mechanism on the OSCOR MEDICAL FIX SCREW PACING LEAD is engineered to anchor the lead securely within heart tissue, ensuring stable electrical conduction for pacing therapy. This design is particularly advantageous in scenarios where lead dislodgment is a risk, such as in patients with irregular heart rhythms or those requiring long-term pacing support. The screw’s anchoring helps maintain consistent pacing performance over time.