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

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Unknown
FDA source (opens on fda.gov)

ONU is the FDA product code for Drug-Eluting Peripheral Transluminal Angioplasty Catheter, a class III device type. FDA's definition for this code reads: "A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended...". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
ONU
Device name
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA definition
A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral.
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

12 of 19 companies shown, in name order