Heartport Endovenous Drainage Cannula

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

510(k) Number

K962835 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Directflow Arterial Cannula

  Class II

  FDA 510(k) K990772 Active Cleared 23 Mar 1999

• Heartport Endosinus Catheter

  Class II

  FDA 510(k) K961270 Active Cleared 18 Jun 1996

• Heartport Needle Trocar

  Class II

  FDA 510(k) K965051 Active Cleared 12 Mar 1997

• Heartport Endopulmonary Vent Catheter

  Class II

  FDA 510(k) K981009 Active Cleared 4 Sep 1998

• Heartport Introducer Sheath

  Class II

  FDA 510(k) K972570 Active Cleared 1 Oct 1997

• Heartport Endopulmonary Vent

  Class II

  FDA 510(k) K961245 Active Cleared 18 Jun 1996

See all devices from Heartport, Inc. →

• What is the primary clinical purpose of the Heartport Endovenous Drainage Cannula during cardiac surgery?

  The Heartport Endovenous Drainage Cannula is specifically designed to drain non-oxygenated blood during cardiopulmonary bypass procedures. This supports circulatory assistance when the heart is temporarily stopped or bypassed, ensuring efficient removal of venous blood to maintain the bypass circuit’s function.

• Is the Heartport Endovenous Drainage Cannula intended for reuse in clinical settings?

  No, the device is explicitly labeled for single-use only in controlled surgical environments like operating rooms. This designation aligns with standard practices for vascular catheters to ensure patient safety and sterility.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Heartport Endovenous Drainage Cannula received FDA 510(k) clearance under the Traditional Review pathway, determined to be substantially equivalent to predicate devices. It is classified as a Class II medical device under FDA regulation 870.4210, reflecting its role in cardiopulmonary bypass procedures.

• Are there multiple sizes or models available for the Heartport Endovenous Drainage Cannula?

  The provided regulatory data does not specify exact sizes or distinct models for the Heartport Endovenous Drainage Cannula. However, the device is listed under multiple FEI numbers in OpenFDA, which may correspond to variations in design or specifications. For precise sizing details, refer to the manufacturer’s product catalog or technical documentation.

• How should the Heartport Endovenous Drainage Cannula be stored before use?

  While the regulatory data does not detail sterility or packaging specifics, the device is intended for single-use in surgical settings, implying it should be stored in its original, sealed packaging to maintain sterility until use. Follow manufacturer guidelines for storage conditions (e.g., temperature, humidity) to preserve functionality.