Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

QSK · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: QSK
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

Definition

Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown