510(k) K142359
K142359 is an FDA 510(k) premarket notification submitted by Lepu Medical Technology (Beijing) Co., Ltd. for the device "Vasc Band hemostat". The FDA issued a decision of Substantially Equivalent on October 23, 2014. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Lepu Medical Technology (Beijing) Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2014
- Date Received
- August 25, 2014
- 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