# K990396: T-Anastaflo

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences Research Medical
- Decided: Oct 1, 1999 after 234 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972261 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972261: Rivetti-Levinson Instraluminal Shunt, Integra Neurocare, LLC (1997) Summary page 1.

## Most influential descendants
- K032977: JMS Bypass Tube (2004), 0 descendants of its own

## Recalls of this device
- Jul 30, 2013 · Class II · Z-1963-2013: Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts.

## Indications for use
The T-AnastaFlo is indicated for use in preventing ischemia by the shunting and/or perfusion of blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts.

Source page: https://510kreport.com/device/K990396
Methodology: https://510kreport.com/methodology