# K202330: Impella XR Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Dec 7, 2020 after 112 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: 5 generations back to K902469 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180785: iSLEEVE Introducer Set, Boston Scientific Corporation (2018) Summary page 4.
- K780532: Percutaneous Sheath Introducer Kit, Arrow Intl., Inc. (1978) Summary page 4.

## Indications for use
The Impella XR Sheath Set is intended for use for the percutaneous introduction of the Impella 2.5 Catheter and ancillary devices.

Source page: https://510kreport.com/device/K202330
Methodology: https://510kreport.com/methodology