Nova Balloon Thermodilution Catheter

• 20 recalls, same reason

  • Terminated Z-0999-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-0995-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1002-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1001-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1014-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-0996-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1003-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1000-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1013-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1009-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1010-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1012-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1004-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1011-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1007-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-0998-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-0997-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1005-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1008-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1006-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005

  Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.

Full name

Nova Balloon Thermodilution Cath.

510(k) Number

K841639 ↗

FDA Product Code

DYG

Device Class

Class II

Regulation

21 CFR Part 870.1240

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Balloon Wedge Pressure, Angiographic

  Class II

  FDA 510(k) K822806 Active Cleared 1 Nov 1982

• Nova Balloon Thermodilution Infusion

  Class II

  FDA 510(k) K832287 Active Cleared 19 Oct 1983

• Dual-Thermistor Thermodilution Cath. & Infu. Cath.

  Class II

  FDA 510(k) K872770 Active Cleared 15 Oct 1987

• Heparin Coated Balloon Thermodilu

  Class II

  FDA 510(k) K834036 Active Cleared 10 Jan 1984

• Nova Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K853625 Active Cleared 15 Jan 1986

• Nova Balloon Thermodilution Pressure Trans Cath

  Class II

  FDA 510(k) K860526 Active Cleared 2 May 1986

See all devices from Nova Medical Specialties →

• What is the primary clinical use of the Nova Balloon Thermodilution Catheter in a cardiac catheterization lab?

  The Nova Balloon Thermodilution Catheter is specifically designed for measuring cardiac output using thermodilution principles. Its balloon-tipped design helps ensure accurate positioning within the pulmonary artery, allowing clinicians to perform precise hemodynamic assessments during procedures in the cardiac catheterization lab.

• Is this catheter intended for reuse, or is it meant to be used only once?

  The Nova Balloon Thermodilution Catheter is explicitly labeled for single-use only. This designation aligns with standard practices for invasive medical devices to ensure patient safety and sterility, preventing cross-contamination between patients.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in the U.S.?

  The device underwent a Traditional 510(k) review with the FDA’s Cardiovascular Advisory Committee (CV), receiving a Substantially Equivalent (SESE) determination in 1984. This means the FDA concluded it is as safe and effective as a legally marketed predicate device, allowing authorized use in the U.S. under the specified indications for cardiac output measurement.

• How is the catheter supplied, and are there different sizes or models available?

  While the exact sizes or models aren’t detailed in the provided data, the device is categorized under OpenFDA’s product code DYG (Flow-Directed Catheter) and has multiple registration numbers listed, suggesting it may come in various configurations to accommodate different patient sizes or procedural needs. For precise sizing or model specifics, consult the manufacturer’s packaging or technical documentation.

• Does the device require any special handling or storage conditions before use?

  The data does not specify storage conditions, but as a single-use, sterile medical device, it should be stored in its original, sealed packaging away from moisture, extreme temperatures, or direct sunlight. Always follow the manufacturer’s instructions for optimal shelf life and sterility preservation, as improper storage could compromise performance or safety.