510(k) K210006
K210006 is an FDA 510(k) premarket notification submitted by Biorep Technologies, Inc. for the device "MI DeTACH". The FDA issued a decision of Substantially Equivalent on March 4, 2021. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2021
- Date Received
- January 4, 2021
- 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