Lemaitre Vascular, Inc.

Address:63 SECOND AVENUE,BURLINGTON,MA,01803,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, Embolectomy (DXE) (5) Assembly, Thigh/Knee/Shank/Ankle/Foot, External (KFX) (4) Spatula, Surgical, General & Plastic Surgery (GAF) (1)

Premarket Exempt

No Yes

Clear

VascuTape Radiopaque Tape - 00840663100378 Catalog Number : 1102-50

Device Description : LeMaitre Stent Guide (50 Strips)

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : KFX

Prescription Use : Yes

Device Count : 1

VascuTape Radiopaque Tape - 00840663100385 Catalog Number : 1108-20

Device Description : Glow 'N Tell 55cm Tape (20 Strips)

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : KFX

Prescription Use : Yes

Device Count : 1

VascuTape Radiopaque Tape - 00840663100392 Catalog Number : 1109-20

Device Description : LeMaitre 550 mm Stent Guide (20 Strips)

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : KFX

Prescription Use : Yes

Device Count : 1

VascuTape Radiopaque Tape - 00840663100408 Catalog Number : 1109-50

Device Description : LeMaitre 550 mm Stent Guide (50 Strips)

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : KFX

Prescription Use : Yes

Device Count : 1

InvisiGrip Vein Stripper - 00840663100415 Catalog Number : 1500-01

Device Description : InvisiGrip Vein Stripper

Device Class : 1

Duns Number: 184805166

Premarket Exempt : No

Product Code : GAF

Prescription Use : Yes

Device Count : 1

LeMaitre Embolectomy Catheter - 00840663100439 Catalog Number : 1601-24

Device Description : 2F 40 cm LeMaitre Embolectomy Catheter

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

LeMaitre Embolectomy Catheter - 00840663100446 Catalog Number : 1601-26

Device Description : 2F 60 cm LeMaitre Embolectomy Catheter

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

LeMaitre Embolectomy Catheter - 00840663100453 Catalog Number : 1601-28

Device Description : 2F 80 cm LeMaitre Embolectomy Catheter

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

LeMaitre Embolectomy Catheter - 00840663100460 Catalog Number : 1601-34

Device Description : 3F 40 cm LeMaitre Embolectomy Catheter

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

LeMaitre Embolectomy Catheter - 00840663100477 Catalog Number : 1601-38

Device Description : 3F 80 cm LeMaitre Embolectomy Catheter

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

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