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

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Unknown
FDA source (opens on fda.gov)

PFV is the FDA product code for System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment, a class III device type. FDA's definition for this code reads: "An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
PFV
Device name
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA definition
An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
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
1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order