# P100030: Arterx Surgical Sealant

- Pathway: PMA
- Applicant: Baxter Healthcare Corporation
- Decided: Mar 1, 2013 after 948 days
- Product code: NBE (Sealant, Polymerizing)
- 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
- Dec 6, 2023 · Class II · Z-0660-2024: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for
- Oct 17, 2014 · Class II · Z-2687-2017: Product was improperly labeled leading to improper storage.

Source page: https://510kreport.com/device/P100030
Methodology: https://510kreport.com/methodology