# K032977: JMS Bypass Tube

- Pathway: 510(k) (Traditional)
- Applicant: Jms North America Corp.
- Decided: May 25, 2004 after 244 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
Longest line of descent: 2 generations back to K972261 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990396: T-Anastaflo, Edwards Lifesciences Research Medical (1999) Summary page 1.

## Indications for use
JMS Bypass Tube is intended to be used to internally shunt blood vessel during anastomosis constructions. The shunt allows blood to be delivered distally past the anastomosis site preventing ischemia while the target coronary artery is opened and surgical grafted to a donor vessel. The bypass shunt is to be removed prior to the final sutures being performed. Select the blood vessel bypass tube which is appropriate for the internal diameter of the blood vessel.

Source page: https://510kreport.com/device/K032977
Methodology: https://510kreport.com/methodology