# K831751: Lead Introducer Sets-EB-S8 & EB-S12

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Oct 20, 1983 after 141 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
- Jun 13, 2005 · Not classified · Z-1443-05: A manufacturer of Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.

Source page: https://510kreport.com/device/K831751
Methodology: https://510kreport.com/methodology