# K053400: Acumen Single-Lumen Delivery Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Acumen Medical, Inc.
- Decided: Jun 19, 2006 after 195 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 K893658 (1989). 31 ancestors in all.
11 later devices descend from it; 2 cite 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)
- K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve, Thomas Medical Products, Inc. (2001) Summary page 1.
- K012130: Attain LDS 6216 Left-Heart Delivery System, Medtronic Vascular (2001) Summary page 1.
- K012083: Attain Access 6218 Left-Heart Delivery System, Model 6218, Medtronic Vascular (2001) Summary page 1.

## Most influential descendants
- K070396: Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45 (2007), 10 descendants of its own
- 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

## Indications for use
The 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/K053400
Methodology: https://510kreport.com/methodology