# K972261: Rivetti-Levinson Instraluminal Shunt

- Pathway: 510(k) (Traditional)
- Applicant: Integra Neurocare, LLC
- Decided: Sep 15, 1997 after 90 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.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K990396: T-Anastaflo (1999), 1 descendant of its own
- K032977: JMS Bypass Tube (2004), 0 descendants of its own

## Indications for use
The Rivetti-Levinson Intraluminal Shunt is indicated for use in preventing ischemia during the construction of coronary artery bypass grafts (either saphenous vein or of mammary artery) in the non-arrested heart. Intraluminal shunting is indicated for temporary perfusion of the distal coronary lumen as an adjunct to the surgical technique and as a mechanism to prevent myocardial ischemia while the target coronary artery is opened and surgically grafted to a donor vessel. This device should only be used by a physician or qualified personnel under the direction of a physician. Care must be taken to ensure compliance with the manufacturer’s instructions for use.

Source page: https://510kreport.com/device/K972261
Methodology: https://510kreport.com/methodology