Modified Schneider-Shilley Flushing Catheter

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

Full name

Modified Schneider-Shiley Flushing Catheter

510(k) Number

K875326 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modified Schneider Shiley Inflation Syringes

  Class II

  FDA 510(k) K875324 Active Cleared 25 Mar 1988

• Modified Schneider-Shiley Pressure Manometer

  Class II

  FDA 510(k) K875322 Active Cleared 28 Mar 1988

• Softrac-PTA(Tm) Peripheral Dilatation Catheter

  Class II

  FDA 510(k) K881197 Active Cleared 16 May 1988

• Modified Occluder/Flushing Catheter Stopcock

  Class II

  FDA 510(k) K875325 Active Cleared 18 Feb 1988

• Modified Seldinger Initial Puncture Instrument

  Class II

  FDA 510(k) K875327 Active Cleared 25 Mar 1988

• Modified Peripheral Dilatation Catheters

  Class II

  FDA 510(k) K875175 Active Cleared 28 Jul 1988

See all devices from Schneider-Shilley (Usa) →

• What is the Modified Schneider-Shilley Flushing Catheter used for?

  This catheter is designed specifically for flushing and maintaining the patency of vascular access sites during cardiovascular procedures. By ensuring clear lumen pathways, it facilitates the safe administration of contrast media or therapeutic agents, which is critical for accurate diagnostic imaging and successful interventions.

• Is the Modified Schneider-Shilley Flushing Catheter single-use or reusable?

  The device is supplied as a single-use catheter. This design choice aligns with standard medical practice for intravascular devices to minimize infection risks and ensure sterility, as reuse could compromise integrity and introduce contamination.

• How should the Modified Schneider-Shilley Flushing Catheter be stored?

  Storage should follow standard aseptic techniques for single-use medical devices. This includes keeping the catheter in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve sterility and functionality until use.

• What regulatory clearance does the Modified Schneider-Shilley Flushing Catheter hold?

  The catheter received FDA 510(k) clearance (K875326) in 1988 under the Traditional clearance type, with a decision of Substantially Equivalent by the Cardiovascular Advisory Committee. This classification indicates it meets regulatory standards for safety and effectiveness as a diagnostic intravascular catheter.

• What product code category does the Modified Schneider-Shilley Flushing Catheter fall under?

  The device is classified under product code DQO, which categorizes it as a diagnostic catheter used in cardiovascular procedures. This classification helps healthcare providers and regulatory bodies identify its intended use and application within medical settings.