# P100009: Mitraclip Delivery System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Oct 24, 2013 after 1,330 days
- Product code: NKM (Mitral Valve Repair Devices)
- Device class: 3
- Recalls of this device: 1 (1 Class I)
- 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.
1 of 1 device in its family (counting itself) has a Class I recall.

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

## Recalls of this device
- Feb 4, 2016 · Class I · Z-0911-2016: Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be d

Source page: https://510kreport.com/device/P100009
Methodology: https://510kreport.com/methodology