510(k) K191827
K191827 is an FDA 510(k) premarket notification submitted by Sunny Medical Device (Shenzhen) Co., Ltd. for the device "Sunmed Disposable Angio-Closure Pads". The FDA issued a decision of Substantially Equivalent on March 16, 2020. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Sunny Medical Device (Shenzhen) Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2020
- Date Received
- July 8, 2019
- 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