VascuteK Graft Sizer Set

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

510(k) Number

K955588 ↗

FDA Product Code

DSY

Device Class

Class II

Regulation

21 CFR Part 870.3450

Advisory Committee

Cardiovascular

FDA Decision

ST

• Minature Pressure Transducer

  Class II

  FDA 510(k) K834040 Active Cleared 10 Feb 1984

• Hydroxylapatite Alveolar Ridge Main

  Class II

  FDA 510(k) K810382 Active Cleared 20 Mar 1981

• Valve Sizer

  Class I

  FDA 510(k) K934951 Active Cleared 10 Dec 1993

• Pyrolite Carbon Alveolar Mainten Implant

  Class II

  FDA 510(k) K791416 Active Cleared 9 Oct 1979

• Carbomedics Supra-Annular Valve Sizer

  Class I

  FDA 510(k) K952184 Active Cleared 29 Nov 1995

• Carbomedics Mitral Rotator

  Class I

  FDA 510(k) K960923 Active Cleared 29 Apr 1996

See all devices from Carbomedics, Inc. →

• What is the VascuteK Graft Sizer Set used for?

  The VascuteK Graft Sizer Set is a prosthesis used in cardiovascular applications for vascular grafts of 6mm and greater diameter, as defined in its device specifications.

• Is the VascuteK Graft Sizer Set supplied sterile or non-sterile?

  The device is supplied non-sterile, as stated in the specifications, and is intended for reuse after appropriate cleaning and sterilization by the user.

• Can the VascuteK Graft Sizer Set be reused?

  Yes, the device is intended for reuse, as indicated in the description, and is supplied non-sterile to allow for reprocessing before each use.

• What sizes or models are included in the VascuteK Graft Sizer Set?

  The set is designed for vascular grafts of 6mm and greater diameter, but specific size increments or individual components within the set are not detailed in the provided specifications.

• How should the VascuteK Graft Sizer Set be stored?

  Storage and handling details are not specified in the available specifications, so users should follow standard medical device practices for non-sterile reusable instruments unless otherwise directed by the manufacturer.