Duo Venous Stent System
FDA premarket approval P230021 · decided 2023-12-26
Approval details
- PMA number
- P230021
- Trade name
- Duo Venous Stent System
- Generic name
- Stent, iliac vein
- Applicant
- Philips Image Guided Therapy Corporation
- Date received
- 2023-07-03
- Decision date
- 2023-12-26
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- The Duo Venous Stent System is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The Duo Hybrid is intended to be used in the iliac vein at the confluence of the inferior vena cava only. The Duo Extend is intended for use in the common iliac and common femoral veins.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IntraSight Plus (K253714) | Philips Image Guided Therapy Corporation | 2026-02-24 |
| VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (K251103) | Philips Image Guided Therapy Corporation | 2025-05-09 |
| VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter (K200812) | Philips Image Guided Therapy Corporation | 2020-09-02 |
| Reconnaissance PV .018 OTW Digital IVUS Catheter (K200410) | Philips Image Guided Therapy Corporation | 2020-05-22 |