# Volcano Atheromed, Inc.

- Location (FDA's records): Menlo Park, CA
- FDA decisions: 7 (2014–2021): 7 510(k) clearances
- Product codes: MCW (6), QEZ (1)
- 510(k) review time since 2016: median 55 days, against 103 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 7 (5 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
- Atheromed, Inc.: 5 (https://510kreport.com/company/atheromed)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)
- Medrad, Inc.: 1 (https://510kreport.com/company/medrad)

## Firms that cite its devices most
- Vesalio, Inc.: 1 (https://510kreport.com/company/vesalio)
- Avantec Vascular Corp.: 1 (https://510kreport.com/company/avantec-vascular)

## Its most-cited devices
- K193197: QuickClear Mechanical Thrombectomy System (2020), cited by 2
- K172386: 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System (2017), cited by 2
- K143328: 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip (2014), cited by 1
- K182972: Phoenix Atherectomy System (2018), cited by 1
- K151145: 2.4mm X 127 cm Phoenix Atherectomy Deflecting System (2015), cited by 1

## Recent decisions
- K211518: 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System (Jun 14, 2021)
- K193197: QuickClear Mechanical Thrombectomy System (Apr 20, 2020)
- K182972: Phoenix Atherectomy System (Dec 20, 2018)
- K181877: Phoenix 2.4mm Atherectomy Plus System (Dec 17, 2018)
- K172386: 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System (Aug 24, 2017)
- K151145: 2.4mm X 127 cm Phoenix Atherectomy Deflecting System (May 26, 2015)
- K143328: 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip (Dec 19, 2014)

Source page: https://510kreport.com/company/volcano-atheromed