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

Scaffold, Dissection Repair

Unknown
FDA source (opens on fda.gov)

QCT is the FDA product code for Scaffold, Dissection Repair, a class III device type. FDA's definition for this code reads: "For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity arteries". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QCT
Device name
Scaffold, Dissection Repair
FDA definition
For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity arteries
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code