Device Atlas

Scaffold, Dissection Repair

FDA product code QCT · Class III (high risk) · Cardiovascular

For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity arteries

0510(k) clearances

2PMA approvals

1recalls

Implantimplanted device

PMA approvals

P190027 Tack Endovascular System (4F, 1.5-4.5mm) · Philips Image Guided Therapy Corporation (Formerly Intact) · 04/10/2020
P180034 Tack Endovascular System (6F) · Philips Image Guided Therapy Corporation · 04/11/2019

Recall	Product	Firm	Initiated
Z-1070-2025 Class I	Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack…Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by…	Spectranetics Corporation	01/10/2025Open, Classified