Schneider 8 Fr. Stamina Guiding Catheter

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

Full name

Schneider 8 Fr. Stamina(Tm) Guiding Catheter

510(k) Number

K920157 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• PTA Balloon Catheter

  Class II

  FDA 510(k) K915349 Active Cleared 11 Feb 1992

• Schneider Monorail(Tm) Softrac-PTA(Tm) Catheter

  Class II

  FDA 510(k) K902091 Active Cleared 26 Sep 1990

• Biliary Endoprostheses W/Unistep Delivery System

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  FDA 510(k) K925406 Active Cleared 11 Jan 1995

• Schneider Magnarail Probing Catheter

  Class II

  FDA 510(k) K910259 Active Cleared 18 Apr 1991

• Schneider Monorail-Pmc Pressure Monitoring Cath.

  Class II

  FDA 510(k) K896741 Active Cleared 28 Feb 1990

• Schneider Hydro-Sil Guidewire

  Class II

  FDA 510(k) K925804 Active Cleared 12 Feb 1993

See all devices from Schneider Intl., Ltd. →

• What is the primary use of the Schneider 8 Fr. Stamina Guiding Catheter in cardiovascular procedures?

  The Schneider 8 Fr. Stamina Guiding Catheter is designed to assist in the precise delivery and stable positioning of interventional devices, such as pacemaker leads, within the heart’s venous system. It is specifically intended for use during implantation or revision procedures to ensure accurate placement.

• Is the Schneider 8 Fr. Stamina Guiding Catheter compatible with MRI environments, and if so, under what conditions?

  Yes, the catheter is explicitly stated to be compatible with MRI environments, though the exact conditions for compatibility are not detailed in the provided data. Always verify the manufacturer’s guidelines for specific MRI safety protocols before use.

• How should the Schneider 8 Fr. Stamina Guiding Catheter be stored, and what precautions should be taken?

  The catheter must be stored while protected from extreme temperatures and mechanical damage. Since it is supplied sterile and intended for single-use, ensure it remains in its original packaging until ready for immediate use to maintain sterility and integrity.

• Is this catheter reusable, or is it intended for single-use only?

  The Schneider 8 Fr. Stamina Guiding Catheter is explicitly labeled as intended for single-use only. This designation ensures patient safety and sterility, as reuse could compromise these critical factors.

• What is the regulatory pathway for the FDA clearance of this device, and what classification does it fall under?

  The device holds FDA 510(k) clearance under classification DXY (product code) and regulatory number 870.3610, with a decision described as *Substantially Equivalent* to a predicate device. It was reviewed by the Cardiovascular (CV) Advisory Committee and received clearance on March 16, 1992, under the traditional 510(k) pathway.