# DEN150029: Permaseal

- Pathway: De Novo (Direct)
- Applicant: Micro Interventional Devices,Inc.
- Decided: Jul 27, 2016 after 401 days
- Product code: PNQ (Apical Closure Device)
- Device class: 2
- Regulation: 21 CFR 870.4510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
soft tissue approximation of cardiac apical tissue during transcatheter valve replacement procedures

Source page: https://510kreport.com/device/DEN150029
Methodology: https://510kreport.com/methodology