# P930038: Angio Seal Vascular Closure Device

- Pathway: PMA
- Applicant: Terumo Medical Corporation
- Decided: Sep 30, 1996 after 1,068 days
- Product code: MGB (Device, Hemostasis, Vascular)
- 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
- Apr 9, 2018 · Class II · Z-2337-2018: Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as inte
- Aug 22, 2005 · Not classified · Z-0677-06: Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.

Source page: https://510kreport.com/device/P930038
Methodology: https://510kreport.com/methodology