Vascoscrew 6/60 and Vascoscrew 8/60

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

510(k) Number

K914121 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascotwist 9/60

  Class III

  FDA 510(k) K920662 Active Cleared 24 Nov 1993

• Vasco Tip/Vascoflange

  Class III

  FDA 510(k) K913831 Active Cleared 25 Aug 1993

• What are the Vascoscrew 6/60 and Vascoscrew 8/60 primarily used for in clinical practice?

  The Vascoscrew 6/60 and Vascoscrew 8/60 are screw-in lead electrodes designed for implantation in the cardiovascular system. They provide stable electrical contact within cardiac tissue to support reliable pacing applications, ensuring effective cardiac rhythm management for patients requiring permanent pacemaker therapy.

• Are these devices intended for reuse, or are they meant to be used only once?

  The Vascoscrew 6/60 and Vascoscrew 8/60 are explicitly labeled as intended for single-use only. This designation ensures patient safety and sterility, as they are supplied sterile and not designed for repeated implantation.

• What distinguishes the Vascoscrew 6/60 from the Vascoscrew 8/60 in terms of sizing or application?

  The model numbers 6/60 and 8/60 refer to the specific sizes of the screw-in electrodes, where the first digit (6 or 8) likely indicates the gauge or diameter of the lead. These variations allow clinicians to select the appropriate size for the patient’s anatomy or procedural requirements during cardiovascular implantation.

• How should these devices be stored before use, and what precautions should be taken?

  Since the Vascoscrew 6/60 and Vascoscrew 8/60 are supplied sterile, they must be stored in their original packaging until ready for use. Proper storage involves maintaining the sterile barrier, protecting from contamination, and adhering to manufacturer guidelines to preserve integrity. Avoid exposure to extreme temperatures or moisture, as these could compromise sterility or functionality.

• What regulatory pathway was followed for FDA clearance of these devices, and what does that mean for clinicians?

  The Vascoscrew 6/60 and Vascoscrew 8/60 were cleared via a traditional 510(k) pathway (K914121) under FDA regulation 870.3680, with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee. This means the devices were compared to a legally marketed predicate and deemed safe and effective for their intended use as permanent pacemaker electrodes, ensuring compliance with U.S. medical device standards.