510(k) K131411
K131411 is an FDA 510(k) premarket notification submitted by Jilin Coronado Medical , Ltd. for the device "COSEAL". The FDA issued a decision of Substantially Equivalent on September 26, 2013. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Jilin Coronado Medical , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2013
- Date Received
- May 15, 2013
- 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