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

Unit, electrosurgical, endoscopic (with or without accessories) (KNS) (6) Choledochoscope and accessories, flexible/rigid (FBN) (1) Computer, diagnostic, programmable (DQK) (1) Endoscope channel accessory (ODC) (1) Submucosal injection agent (PLL) (1)

Premarket Exempt

No Yes

Clear

ORISE™ Gel - 08714729993858 Catalog Number : M00519230

Device Description : Submucosal lifting agent with needle.

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 1

RHYTHMIA HDx™ - 08714729994077 Catalog Number :

Device Description : Mapping System

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

SpyGlass™ Discover - 08714729994183 Catalog Number :

Device Description : Digital Catheter

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : FBN

Prescription Use : Yes

Device Count : 1

AutoCap™ RX - 08714729994701 Catalog Number : 4510

Device Description : Integrated Biopsy Cap and Guidewire Locking Device

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

ORISE™ ProKnife - 08714729995555 Catalog Number :

Device Description : Electrosurgical knife

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

ORISE™ ProKnife - 08714729995562 Catalog Number :

Device Description : Electrosurgical knife

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

ORISE™ ProKnife - 08714729995579 Catalog Number :

Device Description : Electrosurgical knife

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

ORISE™ ProKnife - 08714729995586 Catalog Number :

Device Description : ORISE 1.5 mm Electrode - Kitted Device

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

ORISE™ ProKnife - 08714729995593 Catalog Number :

Device Description : ORISE 2.0 mm Electrode - Kitted Device

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

ORISE™ ProKnife - 08714729995609 Catalog Number :

Device Description : ORISE 3.0 mm Electrode - Kitted Device

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

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