510(k) K222184
K222184 is an FDA 510(k) premarket notification submitted by Beijing Demax Medical Technology Co.,Ltd for the device "Introducer Sheath Kits". The FDA issued a decision of Substantially Equivalent on February 21, 2023. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Beijing Demax Medical Technology Co.,Ltd has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2023
- Date Received
- July 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type