510(k) K170726
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2017
- Date Received
- March 9, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Biopsy, Endomyocardial
- Device Class
- Class II
- Regulation Number
- 870.4075
- Review Panel
- CV
- Submission Type