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

Drug-Coated Peripheral Transluminal Angioplasty Catheter

Unknown
FDA source (opens on fda.gov)

PRC is the FDA product code for Drug-Coated Peripheral Transluminal Angioplasty Catheter, a class III device type. FDA's definition for this code reads: "Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
PRC
Device name
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA definition
Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
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