510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MAFClass III

Stent, Coronary

Unknown
FDA source (opens on fda.gov)

MAF is the FDA product code for Stent, Coronary, a class III device type. FDA's definition for this code reads: "The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen". As of , FDA records hold no 510(k) clearances under this code and 22 recalls.

Classification record

Product code
MAF
Device name
Stent, Coronary
FDA definition
The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
22

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order