Amplantz and Bentson Guidewires

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

510(k) Number

K912798 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiac Electrode K760443

  Class III

  FDA 510(k) K760443 Active Cleared 26 Aug 1976

• Meadox Exxcel Eptfe Vascular Graft

  Class II

  FDA 510(k) K962433 Active Cleared 17 Mar 1997

• Ms Classique Balloon Catheter

  Class II

  FDA 510(k) K942293 Active Cleared 18 Oct 1994

• Meadox(R) Surgimed Olbert Catheter System(R)

  Class II

  FDA 510(k) K921706 Active Cleared 20 May 1993

• Naviguide Hydrophilic Guide Wire

  Class II

  FDA 510(k) K943358 Active Cleared 2 Jun 1995

• Hemashield Microvel Velour Knitted Vascular Graft

  Class II

  FDA 510(k) K954848 Active Cleared 1 Feb 1996

See all devices from Meadox Medicals, Div. Boston Scientific Corp. →

• What are the Amplatz and Bentson Guidewires used for?

  These guidewires are designed for percutaneous vascular procedures, providing structural support and pathway guidance during the placement of catheters or other devices through complex or tortuous blood vessels. Their stainless steel core and flat-wire coil construction allow for precise navigation, reducing vessel trauma while delivering heavier instruments.

• Are the Amplatz and Bentson Guidewires sterile and single-use?

  No, these guidewires are supplied as single-use but are non-sterile. They are intended for use in controlled clinical settings like catheterization labs or operating rooms, where sterile technique must be applied if used in invasive procedures. Sterility is not inherent to the packaging.

• What tip configurations and diameters are available?

  The guidewires come in various tip configurations and diameters, though exact specifications are not detailed in the provided data. The design variations cater to different procedural needs, such as enhanced flexibility or rigidity, depending on the anatomical challenges being addressed.

• How should these guidewires be stored?

  Storage must follow the manufacturer’s guidelines to preserve the device’s integrity. Since they are non-sterile and single-use, they should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Proper labeling and inventory tracking are recommended to ensure traceability and compliance with biohazard protocols.

• Can these guidewires be used in MRI procedures?

  No, the Amplatz and Bentson Guidewires are not intended for MRI use. Their construction and materials are not compatible with magnetic resonance imaging environments, which could pose risks to both the device and the patient.