510(k) K190806
K190806 is an FDA 510(k) premarket notification submitted by Asset Medikal Tasarim As. for the device "Flowart". The FDA issued a decision of Substantially Equivalent on Feb 20, 2020. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Asset Medikal Tasarim As. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 20, 2020
- Date Received
- Mar 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)