# K122084: Introducer Set, Model Adelante-S Series

- Pathway: 510(k) (Special)
- Applicant: Oscor, Inc.
- Decided: Aug 29, 2012 after 44 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 4 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934901 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
3 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934901: Tear-Away Sheath Introducer Set with Integral Hemostasis Valve, Thomas Medical Products, Inc. (1994) Summary page 1.

## Most influential descendants
- K201116: Abiomed 23 Fr Sheath (2020), 0 descendants of its own
- K192769: Impella CP Introducer (2019), 0 descendants of its own

## Recalls of this device
- Jun 10, 2026 · Class I · Z-2680-2026: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- Jun 10, 2026 · Class I · Z-2678-2026: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- Jun 10, 2026 · Class I · Z-2679-2026: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
- Feb 22, 2021 · Class II · Z-1467-2021: AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the speci

## Indications for use
The introducer sets, Adelante®-S Series are intended for introduction of pacing leads or catheters into the body.

Source page: https://510kreport.com/device/K122084
Methodology: https://510kreport.com/methodology