510(k) K232577
K232577 is an FDA 510(k) premarket notification submitted by Ningbo Dizegens Medical Science Co.,Ltd for the device "Radial Compression Device". The FDA issued a decision of Substantially Equivalent on January 18, 2024. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Ningbo Dizegens Medical Science Co.,Ltd has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2024
- Date Received
- August 25, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type