# K051515: Modified Acumen Sheath, Model TTW 10-65

- Pathway: 510(k) (Special)
- Applicant: Acumen Medical, Inc.
- Decided: Sep 1, 2005 after 85 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: 3 generations back to K003731 (2001). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050015: Modified Acumen Sheath, Model TTWO767, Acumen Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K062145: Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90, LDS-10-64 and LDS-10-64-90 (2006), 2 descendants of its own
- K070197: Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-Sty (2007), 1 descendant of its own
- K083855: Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59 (2009), 0 descendants of its own

## Indications for use
The Acumen Sheath is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Source page: https://510kreport.com/device/K051515
Methodology: https://510kreport.com/methodology