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

Bronchoscope (flexible or rigid) (EOQ) (9) Pancreatic stent, covered, metallic, removable (PCU) (1) Unit, electrosurgical, endoscopic (with or without accessories) (KNS) (1)

Premarket Exempt

No Yes

Clear

Exalt ™ - 00191506007904 Catalog Number : M00542780

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007911 Catalog Number : M0054278H0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007935 Catalog Number : M0054278R0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007942 Catalog Number : M0054278Z0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007959 Catalog Number : M00542790

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007966 Catalog Number : M0054279H0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007980 Catalog Number : M0054279R0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007997 Catalog Number : M0054279Z0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt™ - 00191506008024 Catalog Number : M00542820

Device Description : Monitor Mount

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Axios™ - 00191506008086 Catalog Number : M00553680

Device Description : Stent and Electrocautery - Enhanced Delivery System

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : PCU, KNS

Prescription Use : Yes

Device Count : 1

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