Progreat
by Terumo Medical Corp. 2 variants
510(k) K033583
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033583 | Date12 Dec 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQO
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Progreat Microcatheter System is a coaxial microcatheter designed for peripheral vascular interventions. It is classified as a catheter under the FDA’s product code DQO, intended for use in therapeutic embolization and angiography. The system features a 2.8Fr or 2.4Fr catheter preloaded with compatible guidewires (0.021" GLIDEWIRE® GT for the 2.8Fr or 0.018" GLIDEWIRE® GT for the 2.4Fr), enabling precise navigation within small-diameter vessels. Its design incorporates a tungsten spiral coil and a three-layer structure to maintain lumen integrity and enhance kink resistance.
The Progreat Microcatheter System is supplied as a sterile, single-use device for interventional radiology procedures. It is intended for use in MRI-unsafe environments due to its metallic components and must be handled with sterile technique. Available in two sizes (2.8Fr and 2.4Fr), the system is packaged for immediate procedural use and requires no additional preparation beyond guidewire compatibility. Authorized under FDA 510(k) clearance (K033583), it adheres to cardiovascular device standards and is distributed for clinical use in peripheral vascular applications.
Other devices from Terumo Medical Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Progreat Microcatheter System used for in clinical practice?
The Progreat Microcatheter System is designed specifically for peripheral vascular interventions, including therapeutic embolization and angiography. Its coaxial design, combined with a tungsten spiral coil and three-layer structure, allows for precise navigation through small-diameter vessels, making it ideal for procedures requiring high maneuverability and stability in delicate vascular environments.
How is the Progreat Microcatheter System supplied, and what preparation is required?
The system is supplied sterile and ready for immediate use in interventional radiology procedures. It comes preloaded with compatible guidewires (0.021" GLIDEWIRE® GT for the 2.8Fr or 0.018" GLIDEWIRE® GT for the 2.4Fr), so no additional preparation is needed beyond ensuring guidewire compatibility. The packaging ensures sterility, and the device is intended for single-use only.
Is the Progreat Microcatheter System safe for use in MRI environments?
No, the Progreat Microcatheter System is not MRI-safe due to its metallic components, including the tungsten spiral coil. This design enhances kink resistance and lumen integrity but also makes it unsuitable for use in MRI environments, where metallic objects can interfere with imaging or pose safety risks.
What sizes are available for the Progreat Microcatheter System, and how do they differ?
The Progreat Microcatheter System is available in two sizes: 2.8Fr and 2.4Fr. The 2.8Fr version is preloaded with a 0.021" GLIDEWIRE® GT, while the 2.4Fr version is preloaded with a 0.018" GLIDEWIRE® GT. The smaller 2.4Fr size is designed for even more precise navigation in very small vessels, whereas the 2.8Fr offers a slightly larger lumen for procedures requiring greater flow capacity.
How should the Progreat Microcatheter System be stored before use?
The Progreat Microcatheter System should be stored in its original, unopened packaging to maintain sterility. The packaging is designed for immediate procedural use, so no additional preparation is required beyond ensuring the device is kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow sterile technique when handling the device to prevent contamination.