# K033913: Progreat

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Mar 11, 2004 after 85 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961923 (1996). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 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 2.
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter, Boston Scientific Corp (2003) Summary page 4.

## Most influential descendants
- K171665: Microcatheter and guide-wire system (2018), 1 descendant of its own
- K212719: Micro Catheter and Guidewire System (2022), 0 descendants of its own
- K161967: FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm (2017), 0 descendants of its own

## Indications for use
The ProgreatTM is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis in procedures including but not limited to Uterine Fibroid Embolization. The Progreat should not be used in cerebral vessels.

Source page: https://510kreport.com/device/K033913
Methodology: https://510kreport.com/methodology