Permaseal
FDA 510(k) clearance DEN150029 · decided 2016-07-27
Clearance details
- K-number
- DEN150029
- Device name
- Permaseal
- Applicant
- Micro Interventional Devices,Inc.
- Decision
- Unknown
- Date received
- 2015-06-22
- Decision date
- 2016-07-27
- Days to decision
- 401 days
- Clearance type
- Direct
- Product code
- PNQ
- Device class
- 2
- Regulation number
- 870.4510
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Newtown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.