# K222113: Abiomed 14Fr Low Profile Introducer Set

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Oct 13, 2022 after 87 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
Longest line of descent: 5 generations back to K032073 (2003). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160254: GORE DrySeal Flex Introducer Sheath, W. L. Gore & Associates, Inc. (2016) Summary page 4.

## Most influential descendants
- K241708: Abiomed 14Fr Low Profile Introducer Kit (2024), 1 descendant of its own
- K252766: 14Fr Low Profile Introducer Kit (2025), 0 descendants of its own

## Recalls of this device
- May 26, 2023 · Class II · Z-2128-2023: There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was uninte

## Indications for use
The 14 Fr Low Profile Introducer Set is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices

Source page: https://510kreport.com/device/K222113
Methodology: https://510kreport.com/methodology