510(k) DEN150029
DEN150029 is an FDA 510(k) premarket notification submitted by Micro Interventional Devices,Inc. for the device "Permaseal". The FDA issued a decision of De Novo Granted on July 27, 2016. The device falls under product code PNQ (Apical Closure Device), a Class II device regulated under 21 CFR 870.4510.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 27, 2016
- Date Received
- June 22, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apical Closure Device
- Device Class
- Class II
- Regulation Number
- 870.4510
- Review Panel
- CV
- Submission Type
This device is intended for closure of cardiac apical tissue.