510(k) K220258
K220258 is an FDA 510(k) premarket notification submitted by Avia Vascular for the device "20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)". The FDA issued a decision of Substantially Equivalent on Jul 14, 2022. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 14, 2022
- Date Received
- Jan 31, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type
- 510(k)