510(k) K162027
K162027 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "TRAcelet Compression Device". The FDA issued a decision of Substantially Equivalent on October 21, 2016. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Medtronic Vascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 2016
- Date Received
- July 22, 2016
- 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