Swan-Ganz Heparin Coated, Etc. Catheter

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

510(k) Number

K811411 ↗

FDA Product Code

KRB

Device Class

Class II

Regulation

21 CFR Part 870.1915

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• American Edwards Small Diameter Rigid Endoscope

  Class II

  FDA 510(k) K851374 Active Cleared 28 Jun 1985

• Swan-Ganz Flow-Directed Thermodil Cath

  Class II

  FDA 510(k) K822350 Active Cleared 24 Aug 1982

• American Edwards Mini-Flex Angioscope

  Class II

  FDA 510(k) K842481 Active Cleared 18 Oct 1984

• Edslab Pressure Gauge

  Class II

  FDA 510(k) K832323 Active Cleared 11 Aug 1983

• Peripheral Dilatation Angioplasty-Cath

  Class II

  FDA 510(k) K834429 Active Cleared 10 Aug 1984

• Forgarty Balloon Calibrator

  Class II

  FDA 510(k) K830734 Active Cleared 12 Apr 1983

See all devices from American Edwards Laboratories →

• What is the Swan-Ganz Heparin-Coated Catheter used for?

  The Swan-Ganz Heparin-Coated Catheter is designed for hemodynamic monitoring in critical care settings. It measures cardiac output, pulmonary artery pressure, and central venous pressure in real-time, enabling clinicians to assess cardiac function and guide therapeutic decisions. The thermodilution feature ensures accurate cardiac output determination, while the heparin coating helps minimize the risk of clotting during use.

• How is the Swan-Ganz Heparin-Coated Catheter supplied and what is its sterility status?

  This catheter is supplied as a single-use, sterile device. It is intended for one-time clinical use only and comes pre-packaged to maintain sterility until deployment in environments like intensive care units or operating rooms. The sterile packaging ensures safety and compliance with clinical protocols.

• Is the Swan-Ganz Heparin-Coated Catheter reusable or intended for single-use?

  The Swan-Ganz Heparin-Coated Catheter is explicitly designed for single-use only. It is not intended for reuse, as single-use devices are engineered to maintain sterility, safety, and performance for one patient encounter. Reuse could compromise sterility and increase infection risks, which is why this catheter is packaged and labeled accordingly.

• What reference codes or sizes are available for the Swan-Ganz Heparin-Coated Catheter?

  The Swan-Ganz Heparin-Coated Catheter comes in multiple reference codes to accommodate diverse patient needs and procedural requirements. Some of the available codes include 1721676, 3002806476, 1018233, 1625425, and others. These variations ensure compatibility with different patient anatomies and clinical scenarios, allowing clinicians to select the appropriate size and configuration for their patients.

• How should the Swan-Ganz Heparin-Coated Catheter be stored before use?

  The catheter should be stored in its original, unopened sterile packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Ensure the packaging remains intact until immediate use to preserve sterility. Follow manufacturer guidelines for expiration dates and storage conditions to maintain device integrity and performance.