Pericardiocentesis Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K802289 ↗

FDA Product Code

DOR

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

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 primary clinical use of the Pericardiocentesis Kit, and how does it differ from its secondary function?

  The Pericardiocentesis Kit is primarily designed for the aspiration of pericardial fluid during medical procedures, such as in cases of cardiac tamponade or pericardial effusion. Its secondary function—as noted in its regulatory classification—is for diagnostic use in radioimmunoassay testing for digoxin levels in serum or plasma, though this is not its main purpose. The kit’s core utility remains in fluid extraction, not hormone measurement.

• Is the Pericardiocentesis Kit reusable, and what precautions must be taken during storage?

  The kit is intended for single-use only and must be treated as sterile upon opening. Storage and handling require adherence to sterile procedure protocols to preserve its integrity, as contamination could compromise its safety for pericardiocentesis. Discard after use to prevent cross-contamination.

• What regulatory pathway was followed for FDA clearance, and what does the Product Code DOR indicate?

  The kit received FDA 510(k) clearance (K802289) under the Traditional pathway, deemed *substantially equivalent* to a predicate device. The Product Code DOR classifies it as a Class II diagnostic device, though its primary function is procedural (pericardiocentesis), not diagnostic testing. The original review was under the Clinical Toxicology advisory committee in 1980.

• Are there any MRI safety restrictions for this kit, and how should it be stored before use?

  The kit does not have MRI safety restrictions noted in its documentation, meaning it can be used in MRI-compatible environments without interference. For storage, keep it in its original sterile packaging in a clean, dry place away from direct sunlight or extreme temperatures until ready for use.