Product Code: ONU


Products Classified as ONU

1071Drug-eluting Peripheral Transluminal Angioplasty Catheter

Total Product Life Cycle (TPLC) Devices

1071Drug-eluting Peripheral Transluminal Angioplasty Catheter

FDA Consensus Standards

Drug-Eluting Peripheral Transluminal Angioplasty Catheter [33890]21 CFR Unclassified 🔎
Drug-Eluting Peripheral Transluminal Angioplasty Catheter [38698]21 CFR Unclassified 🔎

Pre-market Approvals for ONU

P160049Stellarex 0.035 OTW Drug-coated Angioplasty BalloonThe Spectranetics Corp.
P140010IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon CatheterMEDTRONIC Inc.
P130024Lutonix 035 Drug Coated Balloon PTA CatheterLUTONIX

Global Unique Device Identification Database

00643169975088Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169975071Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169975064Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169975057Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169975040Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169975033Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169975026Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169975019Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169975002Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169974999Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169974982Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169974975Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169859975Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169859968Drug-Eluting Peripheral Transluminal Angioplasty Catheter
00643169576353Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Maude Adverse Events

STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-31
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-31
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERMEDTRONIC IRELAND2020-03-30
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERMEDTRONIC IRELAND2020-03-27
LUTONIX 035 DRUG COATED BALLOON PTA CATHETERLUTONIX, INC2020-03-26
LUTONIX 035 DRUG COATED BALLOON PTA CATHETERLUTONIX, INC2020-03-26
IN.PACT AV ACCESSMEDTRONIC IRELAND2020-03-26
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-25
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-25
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-25
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-25
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-25
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-25
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-24
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-24
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-24
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-24
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-23
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-23
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-23
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-23
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-23
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-23
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-23
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-23
IN.PACT PACIFICMEDTRONIC IRELAND2020-03-23
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERMEDTRONIC IRELAND2020-03-23
STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-19
STELLAREX 0.014 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-19
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-19
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-19
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-19
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-19
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-19
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-19
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERMEDTRONIC IRELAND2020-03-19
LUTONIX 035 DRUG COATED BALLOON PTA CATHETERLUTONIX, INC2020-03-16
LUTONIX 035 DRUG COATED BALLLOON PTA CATHETERLUTONIX, INC2020-03-09
LUTONIX 035 DRUG COATED BALLOON PTA CATHETERLUTONIX, INC2020-03-09
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-06
IN.PACT AV ACCESSMEDTRONIC IRELAND2020-03-06
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-04
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-04
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-04
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONSPECTRANETICS2020-03-04
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERMEDTRONIC IRELAND2020-03-04
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERMEDTRONIC IRELAND2020-03-04
IN.PACT AV ACCESSMEDTRONIC IRELAND2020-03-04
LUTONIX 018 DRUG COATED BALLOON PTA CATHETERLUTONIX, INC2020-03-02
LUTONIX 018 DRUG COATED BALLOON PTA CATHETERLUTONIX, INC2020-03-02
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