Tack Endovascular System (6F)
FDA premarket approval P180034/S001 · decided 2020-01-28
Approval details
- PMA number
- P180034
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Tack Endovascular System (6F)
- Generic name
- Scaffold, dissection repair
- Applicant
- Philips Image Guided Therapy Corporation
- Date received
- 2019-08-02
- Decision date
- 2020-01-28
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- QCT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for the Tack Endovascular System® (6F, 4.0-8.0mm) for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 4.0mm to 8.0mm for the repair of post percutaneous transluminal balloon angioplasty dissection(s).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |