Implantable Devices

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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

Clamp, Vascular (DXC) (3)

Premarket Exempt

Clear

SMITHWICK Carotid Shunt - 00858764006208 Catalog Number : WR1409

Device Description : Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006215 Catalog Number : WR1409NRS

Device Description : Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long, Non Reinforced Segment

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006222 Catalog Number : WR1409SB

Device Description : Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long, Distal Balloon with sa Carotid Shunt 14 Fr. To 9 Fr., wire reinforced, 11” long, Distal Balloon with safety balloon

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

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