Duo Venous Stent System
FDA premarket approval P230021/S002 · decided 2025-11-18
Approval details
- PMA number
- P230021
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Duo Venous Stent System
- Generic name
- Stent, iliac vein
- Applicant
- Philips Image Guided Therapy Corporation
- Date received
- 2025-07-31
- Decision date
- 2025-11-18
- Days to decision
- 110 days
- Decision code
- APPR
- Product code
- QAN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a design ownership and legal manufacturer located at Philips Image Guided Therapy Corporation (Philips), 5905 Nathan Lane North, Plymouth, MN 55442 and 9965 Federal Drive, Colorado Springs, CO 80921 USA
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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 |