# K994243: Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip, Straightshot Kit, 23 FR, Angled Tip

- Pathway: 510(k) (Special)
- Applicant: Heartport, Inc.
- Decided: May 5, 2000 after 141 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) currently marketed Heartport arterial kits: named in the summary without a submission number

## Most influential descendants
- K090869: Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TD (2009), 0 descendants of its own

## Indications for use
The DirectFlow™ Kit, SoftClamp™ Kit and StraightShot™ Kit are indicated for patients undergoing cardiopulmonary bypass. The DirectFlow, SoftClamp and StraightShot arterial cannulae are intended to deliver oxygenated blood for cardiopulmonary bypass. The DirectFlow and SoftClamp arterial cannulae also allow the hemostatic introduction and removal of the Heartport EndoClamp™ aortic catheter. The DirectFlow arterial cannula is intended for introduction and use through a thoracic trocar or incision. The Autolncisor introducer is intended for use with Heartport arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta

Source page: https://510kreport.com/device/K994243
Methodology: https://510kreport.com/methodology