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

Catheter, peripheral, atherectomy (MCW) (6) Bronchoscope (flexible or rigid) (EOQ) (3) mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator (OTN) (1)

Premarket Exempt

No Yes

Clear

Peripheral ROTAPRO™ - 00191506007133 Catalog Number : H749395141750

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™ - 00191506007140 Catalog Number : H749395142000

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™ - 00191506007157 Catalog Number : H749395142150

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™ - 00191506007164 Catalog Number : H749395142250

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™ - 00191506007171 Catalog Number : H749395142380

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™ - 00191506007188 Catalog Number : H749395142500

Device Description : Rotational Atherectomy Device

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

EXALT™ Model B - 00191506007423 Catalog Number : M00542710

Device Description : Single-Use Bronchoscope

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

EXALT™ Model B - 00191506007454 Catalog Number : M00542730

Device Description : Single-Use Bronchoscope

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

EXALT™ Model B - 00191506007485 Catalog Number : M00542750

Device Description : Single-Use Bronchoscope

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Advantage Ultra System - 00191506007652 Catalog Number : M0068502060

Device Description : Transvaginal Mid-Urethral Sling

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

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