# K885179: Intro-Flex Sheath Introducer W/Amc Thromboshield

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 9, 1989 after 238 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 23, 2024 · Class II · Z-1048-2025: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

Source page: https://510kreport.com/device/K885179
Methodology: https://510kreport.com/methodology