# K252766: 14Fr Low Profile Introducer Kit

- Pathway: 510(k) (Special)
- Applicant: Abiomed, Inc.
- Decided: Oct 8, 2025 after 40 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K032073 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241708: Abiomed 14Fr Low Profile Introducer Kit, Abiomed, Inc. (2024) Summary page 5.

## Indications for use
The Abiomed 14Fr Low Profile Introducer Kit 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/K252766
Methodology: https://510kreport.com/methodology