BOSTON SCIENTIFIC CORPORATION

Address:Two Scimed Place,Maple Grove,MN,55311,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

PROSTHESIS, ESOPHAGEAL (ESW) (7) Catheter, peripheral, atherectomy (MCW) (2) Unit, electrosurgical, endoscopic (with or without accessories) (KNS) (1)

Premarket Exempt

No Yes

Clear

Agile™ Esophageal - 00191506006594 Catalog Number :

Device Description : Partially Covered OTW Stent System

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

Agile™ Esophageal - 00191506006600 Catalog Number :

Device Description : Partially Covered OTW Stent System

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

Agile™ Esophageal - 00191506006617 Catalog Number :

Device Description : Partially Covered OTW Stent System

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

Agile™ Esophageal - 00191506006624 Catalog Number :

Device Description : Fully Covered OTW Stent System

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

Agile™ Esophageal - 00191506006631 Catalog Number :

Device Description : Fully Covered OTW Stent System

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

Agile™ Esophageal - 00191506006648 Catalog Number :

Device Description : Fully Covered OTW Stent System

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

Agile™ Esophageal - 00191506006655 Catalog Number :

Device Description : Fully Covered OTW Stent System

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : ESW

Prescription Use : Yes

Device Count : 1

rezum - 00191506006785 Catalog Number : M006D2201-0032

Device Description : Delivery Device

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

Peripheral ROTAPRO™ - 00191506007119 Catalog Number : H749395141250

Device Description : Rotational Atherectomy Device

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Peripheral ROTAPRO™ - 00191506007126 Catalog Number : H749395141500

Device Description : Rotational Atherectomy Device

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

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