← FDA Medical Device Classifications

Coronary Covered Stent

NIV · f · Unknown

Classification

FDA Product Code
NIV
Device class
f
Regulation
Review panel
CV
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N

Definition

Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.

Market data

Cleared 510(k) submissions
0
Registered establishments
10

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown