# P890045: Gelseal TM Triaxial Vascular Graft

- Pathway: PMA
- Applicant: Carbomedics, Inc.
- Decided: Jan 11, 1993 after 1,239 days
- Product code: MAL (Graft, Vascular, Synthetic/Biologic Composite)
- Device class: 2
- Regulation: 21 CFR 870.3450
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K162803: Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (2017), 1 descendant of its own
- K241070: Gelsoft™ Plus Vascular Prostheses (2024), 0 descendants of its own

## Recalls of this device
- May 15, 2015 · Class II · Z-1912-2015: Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
- May 15, 2015 · Class II · Z-1913-2015: Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

Source page: https://510kreport.com/device/P890045
Methodology: https://510kreport.com/methodology