Right Atrial Line Kit

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

510(k) Number

K802287 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Disposable Constrast Delivery Spike Kit

  Class II

  FDA 510(k) K802329 Active Cleared 3 Oct 1980

• Regional Intravenous Anesthesia Kit

  Class II

  FDA 510(k) K802290 Active Cleared 17 Oct 1980

• Vascular Catheter Wireguides

  Class II

  FDA 510(k) K802260 Active Cleared 10 Oct 1980

• Swan Ganz Catheter Placement Kit

  Class II

  FDA 510(k) K802288 Active Cleared 20 Nov 1980

• Complete Tray Central Venous Pressure

  Class II

  FDA 510(k) K792171 Active Cleared 13 Nov 1979

• Transvenous Pacemaker Electrode Kit

  Class II

  FDA 510(k) K802259 Active Cleared 23 Oct 1980

See all devices from Stanco Medical, Inc. →

• What is the Right Atrial Line Kit used for?

  The Right Atrial Line Kit is designed for insertion into the right atrium of the heart to monitor central venous pressure and provide a route for fluid administration, blood sampling, or hemodynamic assessment. This is particularly useful in critical care settings like intensive care units or cardiac catheterization labs where accurate central venous access is required.

• Is the Right Atrial Line Kit sterile and single-use?

  Yes, the Right Atrial Line Kit is supplied as a sterile, single-use assembly. This ensures safety and reliability for each procedure, preventing contamination and cross-infection risks associated with reuse. Sterility is maintained until the kit is opened for use.

• What components are included in the Right Atrial Line Kit?

  The kit includes a catheter, introducer, and associated tubing. These components work together to facilitate precise placement and functionality during insertion into the right atrium, ensuring accurate monitoring and administration of fluids or samples.

• How should the Right Atrial Line Kit be stored?

  The kit must be stored according to sterile medical device protocols to maintain its integrity before use. This includes keeping it in a sealed, uncontaminated environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until immediate use.

• What regulatory clearance does the Right Atrial Line Kit have?

  The Right Atrial Line Kit holds FDA 510(k) clearance under the product code DQY, with a decision classification of substantially equivalent. It was reviewed by the Cardiovascular Advisory Committee and received clearance on November 20, 1980, without third-party review or combination product designation.