# K070396: Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45

- Pathway: 510(k) (Special)
- Applicant: Acumen Medical, Inc.
- Decided: May 22, 2007 after 99 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: 4 generations back to K893658 (1989). 32 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053400: Acumen Single-Lumen Delivery Sheath, Acumen Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K080500: Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7 (2008), 9 descendants of its own
- K101885: Medtronic C315 Delivery Catheter (2010), 8 descendants of its own
- K190475: Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 (2019), 5 descendants of its own
- K230363: CPS Locator 3D Delivery Catheter (2023), 3 descendants of its own
- K250828: CPS Locator 3D Plus Delivery Catheter (2025), 1 descendant of its own

## Indications for use
The Modified Acumen Single-Lumen Delivery Sheath is intended for the introduction of various types of pacing or defibrillator leads and catheters.

Source page: https://510kreport.com/device/K070396
Methodology: https://510kreport.com/methodology