# Acumen Medical, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 12 (2004–2009): 12 510(k) clearances
- Product codes: DYB (9), DQY (3)
- Predicates its devices cite: 19 (10 its own); citations of its devices by later devices: 12 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Vascular: 3 (https://510kreport.com/company/medtronic-vascular)
- Thomas Medical Products, Inc.: 2 (https://510kreport.com/company/thomas-medical-products)
- Cardima, Inc.: 1 (https://510kreport.com/company/cardima)
- Baxter Edwards: 1 (https://510kreport.com/company/baxter-edwards)
- Mitsubishi Cable America, Inc.: 1 (https://510kreport.com/company/mitsubishi-cable-america)
- Acuson Corp.: 1 (https://510kreport.com/company/acuson)

## Firms that cite its devices most
- Cardio-Optics, Inc.: 1 (https://510kreport.com/company/cardio-optics)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)

## Its most-cited devices
- K042381: Coronary Sinus Visualization System, Model CSVS5508 (2004), cited by 2
- K053400: Acumen Single-Lumen Delivery Sheath (2006), cited by 2
- K080500: Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7 (2008), cited by 1
- K062084: 7F Acumen Coronary Sinus Visualization System, Model CSVS-7-67 (2006), cited by 1
- K042376: Acumen Sheath, Model TTW7807 (2004), cited by 1
- K050015: Modified Acumen Sheath, Model TTWO767 (2005), cited by 1

## Recent decisions
- K083855: Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59 (Feb 17, 2009)
- K080500: Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7 (Mar 13, 2008)
- K070396: Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-8-45, BLS-7-45, BLS-6-45 (May 22, 2007)
- K070051: Acumen Insight Endocardial Visualization System (Apr 6, 2007)
- K070197: Acumen Lead Delivery Sheath with Stylet, Models LDS-10-64-Sty and LDS-10-57-Sty (Feb 23, 2007)
- K062145: Modified Acumen Lead Delivery Sheath, Models LDS-10-57, LDS-10-57-90, LDS-10-64 and LDS-10-64-90 (Aug 23, 2006)
- K062084: 7F Acumen Coronary Sinus Visualization System, Model CSVS-7-67 (Aug 18, 2006)
- K053400: Acumen Single-Lumen Delivery Sheath (Jun 19, 2006)

Source page: https://510kreport.com/company/acumen-medical