# K083855: Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59

- Pathway: 510(k) (Special)
- Applicant: Acumen Medical, Inc.
- Decided: Feb 17, 2009 after 55 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: 6 generations back to K003731 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070197: Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-Sty, Acumen Medical, Inc. (2007) Summary page 1.

## Indications for use
The SPIRITTM Navigable Lead Delivery Catheter is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Source page: https://510kreport.com/device/K083855
Methodology: https://510kreport.com/methodology