Progreat
FDA 510(k) K033583 · Terumo Medical Corp.
510(k) numberK033583
Submission
- Device name
- Progreat
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- November 13, 2003
- Decision date
- December 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Progreat cleared by the FDA?
Progreat (K033583) received a 510(k) decision of Substantially Equivalent on December 12, 2003, 29 days after the submission was received.
What is the product code of K033583?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.