# K241708: Abiomed 14Fr Low Profile Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Aug 6, 2024 after 54 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K032073 (2003). 7 ancestors in all.
1 later device descends 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)
- K222113: Abiomed 14Fr Low Profile Introducer Set, Abiomed, Inc. (2022) Summary page 4.

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

## Recalls of this device
- May 22, 2026 · Class I · Z-2599-2026: Potential for thrombus formation during prolonged use of the introducer.
- May 22, 2026 · Class I · Z-2600-2026: Potential for thrombus formation during prolonged use of the introducer.
- May 22, 2026 · Class I · Z-2601-2026: Potential for thrombus formation during prolonged use of the introducer.
- May 22, 2026 · Class I · Z-2602-2026: Potential for thrombus formation during prolonged use of the introducer.

## 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/K241708
Methodology: https://510kreport.com/methodology