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) (10)

Premarket Exempt

Clear

SMITHWICK Carotid Shunt - 00858764006000 Catalog Number : DB1009P

Device Description : Carotid Shunt 9 Fr., dual balloon, 11” long, with safety balloon

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006017 Catalog Number : DB2000I

Device Description : Carotid Shunt 9 Fr., dual balloon, 15 cm long, with safety balloon

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006024 Catalog Number : DWR1310B

Device Description : Doppler Carotid Shunt 14 Fr To 10 Fr, wire reinforced, 13cm long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006031 Catalog Number : DBD1009PT

Device Description : Doppler Carotid Shunt 9 Fr., dual balloon, 11” long, with safety balloon and T-port

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006048 Catalog Number : DBD1009P

Device Description : Doppler Carotid Shunt 9 Fr., dual balloon, 11” long, with safety balloon

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006055 Catalog Number : DB5000IT

Device Description : Carotid Shunt 9 Fr., dual balloon, 15 cm long, with safety balloon and T-port

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006062 Catalog Number : DB1009PT

Device Description : Carotid Shunt 9 Fr., dual balloon, 11” long, with safety balloon and T-port

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006079 Catalog Number : DWR1409

Device Description : Doppler 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 - 00858764006086 Catalog Number : DWR1409NRS

Device Description : Doppler 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 - 00858764006093 Catalog Number : DWR1409SB

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