Directflow Kit, 24 Fr, Softclamp Kit, 24Fr, Straightshot Kit, 23 Fr, Straight Tip, Straightshot Kit, 23 Fr, Angled Tip

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

510(k) Number

K994243 ↗

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. →