510(k) K170223
K170223 is an FDA 510(k) premarket notification submitted by Ashitaka Factory Of Terumo Corporation for the device "Progreat". The FDA issued a decision of Substantially Equivalent on Jul 21, 2017. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Ashitaka Factory Of Terumo Corporation has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 21, 2017
- Date Received
- Jan 25, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
- 510(k)