Heartport Endopulmonary Vent

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

510(k) Number

K961245 ↗

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 Endoarterial Return Cannual

  Class II

  FDA 510(k) K955121 Active Cleared 10 May 1996

See all devices from Heartport, Inc. →

• What is the purpose of the Heartport Endopulmonary Vent?

  The Heartport Endopulmonary Vent is a pulmonary artery vent catheter used during endovascular cardiopulmonary bypass. It functions by removing blood from the pulmonary artery to facilitate decompression of the heart, helping maintain hemodynamic stability during bypass procedures.

• How is the Heartport Endopulmonary Vent supplied and what is its sterility status?

  The Heartport Endopulmonary Vent is supplied for use in surgical settings by clinicians. As a Class II medical device, it is designed for single use to ensure sterility and prevent cross-contamination between patients.

• What is the regulatory status of the Heartport Endopulmonary Vent?

  The Heartport Endopulmonary Vent is a Class II device cleared under FDA 510(k) with K number K961245. It received clearance on June 18, 1996, and is categorized under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass.

• What sizes and models of the Heartport Endopulmonary Vent are available?

  The device data does not specify available sizes or models for the Heartport Endopulmonary Vent. Clinicians should consult the manufacturer directly for detailed information about sizing options and specific model variations that may be available for different clinical applications.