Philips Image Guided Therapy Corporation

Address:5905 Nathan Lane North,Plymouth,MN,55442,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Drug-Eluting Peripheral Transluminal Angioplasty Catheter (ONU) (10)

Premarket Exempt

Clear

Stellarex™ - 00813132029036 Catalog Number : AB35SX040060135

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Stellarex™ - 00813132029043 Catalog Number : AB35SX050060135

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Stellarex™ - 00813132029050 Catalog Number : AB35SX060060135

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Stellarex™ - 00813132029067 Catalog Number : AB35SX040150080

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Stellarex™ - 00813132029074 Catalog Number : AB35SX040200080

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Stellarex™ - 00813132029081 Catalog Number : AB35SX050150080

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Stellarex™ - 00813132029098 Catalog Number : AB35SX050200080

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Stellarex™ - 00813132029104 Catalog Number : AB35SX060150080

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Stellarex™ - 00813132029111 Catalog Number : AB35SX060200080

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

Stellarex™ - 00813132029128 Catalog Number : AB35SX040150135

Device Description : Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon

Device Class : 3

Duns Number: 118354223

Premarket Exempt : No

Product Code : ONU

Prescription Use : Yes

Device Count : 1

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