# K211078: Progreat Lambda

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Clinical Supply Co., Ltd.
- Decided: Dec 21, 2021 after 253 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915414 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033583: Progreat, Terumo Medical Corp. (2003) Summary page 5.

## Indications for use
Progreat Lambda is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intra-arterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels.

Source page: https://510kreport.com/device/K211078
Methodology: https://510kreport.com/methodology