# P140018: Venaseal Closure System

- Pathway: PMA
- Applicant: Medtronic Vascular, Inc.
- Decided: Feb 20, 2015 after 179 days
- Product code: PJQ (Agent, Occluding, Vascular, Permanent)
- Device class: 3
- Recalls of this device: 2 (0 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.
0 of 1 device in its family (counting itself) have 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
- Mar 23, 2021 · Class III · Z-1564-2021: Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
- Apr 28, 2015 · Class II · Z-1599-2015: Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.

Source page: https://510kreport.com/device/P140018
Methodology: https://510kreport.com/methodology