510(k) K221827
K221827 is an FDA 510(k) premarket notification submitted by Saudi Mais Co. For Medical Products for the device "Mais Central Venous Catheter". The FDA issued a decision of Substantially Equivalent on June 23, 2023. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2023
- Date Received
- June 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type