510(k) K210929
K210929 is an FDA 510(k) premarket notification submitted by Woo Young Medical Co., Ltd. for the device "MagiCath II". The FDA issued a decision of Substantially Equivalent on Sep 13, 2022. 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
- Sep 13, 2022
- Date Received
- Mar 29, 2021
- 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
- 510(k)