Protector Introducer Sheath

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K930808 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 11F Guiding Catheter

  Class II

  FDA 510(k) K963663 Active Cleared 13 Jan 1997

• Ivt 0.014 Track or Ivt 0.014 Accutrack

  Class II

  FDA 510(k) K954622 Active Cleared 29 Apr 1996

• Railwire

  Class II

  FDA 510(k) K954552 Active Cleared 29 Apr 1996

• Ivt 0.014 Ptfe-Coated Trackwire

  Class II

  FDA 510(k) K971688 Active Cleared 11 Dec 1997

• What is the Protector Introducer Sheath used for?

  The Protector Introducer Sheath is designed to facilitate the introduction of .038-inch guidewires during non-vascular procedures. It enables over-the-wire placement of catheters through the skin into a vein or artery by providing a coaxial dilator/sheath assembly with a locking stiffening cannula for stability and ease of use.

• How is the Protector Introducer Sheath supplied?

  The device is supplied as a coaxial dilator/sheath assembly that includes a locking stiffening cannula. This configuration allows for over-the-wire placement, where the guidewire is inserted first, followed by the dilator and sheath as a unit to maintain tract integrity during catheter introduction.

• Is the Protector Introducer Sheath intended for single-use or reuse?

  Based on its design as a coaxial dilator/sheath assembly with a locking stiffening cannula intended for percutaneous introduction in non-vascular procedures, the Protector Introducer Sheath is intended for single-use only. Reuse could compromise sterility, mechanical integrity, and patient safety, and is not supported by the device's specifications or clearance documentation.

• What guidewire size is compatible with the Protector Introducer Sheath?

  The Protector Introducer Sheath is specifically designed for use with .038-inch guidewires. This size compatibility is explicitly stated in the device description, which defines its purpose as facilitating the introduction of .038" guidewires in non-vascular procedures.

• What regulatory pathway was used for the Protector Introducer Sheath?

  The Protector Introducer Sheath was cleared through the FDA 510(k) pathway on March 15, 1994, under submission number K930808. It was determined to be substantially equivalent to a predicate device and is classified as a Class 2 medical device under product code DYB.