Modified Schneider Shiley Inflation Syringes

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

510(k) Number

K875324 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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 Schneider-Shilley Flushing Catheter

  Class II

  FDA 510(k) K875326 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 are Modified Schneider Shiley Inflation Syringes used for?

  These are injector and syringe devices specifically designed for angiographic procedures in cardiovascular applications. They are intended for use in medical procedures requiring precise inflation or injection capabilities.

• What is the regulatory status of these syringes?

  The Modified Schneider Shiley Inflation Syringes received FDA 510(k) clearance on March 25, 1988. They are classified as a Class II medical device under product code DXT with regulation number 870.1650.

• Are these syringes single-use or reusable?

  The device data does not specify whether the Modified Schneider Shiley Inflation Syringes are designed for single-use or multiple reuse. This information would need to be obtained directly from the manufacturer or product documentation.

• What sizes or models of these syringes are available?

  No information regarding specific sizes, models, or variations of the Modified Schneider Shiley Inflation Syringes is provided in the device data. Available configurations would need to be confirmed with the manufacturer.