# P990009: Floseal Matrix/Floseal Matrix Hemostatic Sealant/Proceed Hemostatic Sealant

- Pathway: PMA
- Applicant: Baxter Healthcare Corp
- Decided: Dec 8, 1999 after 289 days
- Product code: PMX (Absorbable Collagen Hemostatic Agent With Thrombin)
- Device class: 3
- Regulation: 21 CFR 878.4490
- Recalls of this device: 3 (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-0667-2024: 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
- May 30, 2018 · Class II · Z-2957-2018: Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.
- Jul 31, 2008 · Not classified · Z-2340-2008: The recall is being conducted as a precautionary measure due to potential discoloration of the FloSeal material noted in six (6) non-medical complaints during delivery by the Endoscopic Applicator.

Source page: https://510kreport.com/device/P990009
Methodology: https://510kreport.com/methodology