QCT · Scaffold, Dissection Repair
· Class 3
Overview
| Product Code | QCT |
|---|---|
| Device Name | Scaffold, Dissection Repair |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity arteries
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P190027 | Tack Endovascular System (4F, 1.5-4.5mm) | Philips Image Guided Therapy Corporation (Formerly Intact) | Apr 10, 2020 | APPR |
| P180034 | Tack Endovascular System (6F) | Philips Image Guided Therapy Corporation | Apr 11, 2019 | APWD |
Top Applicants
- Philips Image Guided Therapy Corporation — 1 clearance
- Philips Image Guided Therapy Corporation (Formerly Intact) — 1 clearance