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

Assembly, Thigh/Knee/Shank/Ankle/Foot, External (KFX) (5) Valvulotome (MGZ) (5)

Premarket Exempt

Yes No

Clear

Expandable LeMaitre Valvulotome - 00840663100118 Catalog Number : 1000-95

Device Description : 1.8mm Expandable LeMaitre Valvulotome, 98 cm, 5 pack

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : MGZ

Prescription Use : Yes

Device Count : 1

Over-the-Wire LeMaitre Valvulotome - 00840663100132 Catalog Number : 1005-00

Device Description : 2.0mm Over-the-Wire LeMaitre Valvulotome, 100 cm

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : MGZ

Prescription Use : Yes

Device Count : 1

Over-the-Wire LeMaitre Valvulotome - 00840663100149 Catalog Number : e1005-00

Device Description : 2.0mm Over-the-Wire LeMaitre Valvulotome, 100 cm, eIFU

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : MGZ

Prescription Use : Yes

Device Count : 1

Over-the-Wire LeMaitre Valvulotome - 00840663100163 Catalog Number : 1006-00

Device Description : 2.0mm Over-the-Wire LeMaitre Valvulotome, 40 cm

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : MGZ

Prescription Use : Yes

Device Count : 1

Expandable LeMaitre Valvulotome - 00840663100309 Catalog Number : 1096-00

Device Description : 1.8mm Expandable LeMaitre Valvulotome, 40 cm

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : MGZ

Prescription Use : Yes

Device Count : 1

VascuTape Radiopaque Tape - 00840663100323 Catalog Number : 1100-00

Device Description : Glow 'N Tell 30cm Tape (100 Strips)

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : KFX

Prescription Use : Yes

Device Count : 1

VascuTape Radiopaque Tape - 00840663100330 Catalog Number : 1100-20

Device Description : Glow 'N Tell 30cm Tape (20 Strips)

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : KFX

Prescription Use : Yes

Device Count : 1

VascuTape Radiopaque Tape - 00840663100347 Catalog Number : 1100-50

Device Description : Glow 'N Tell 30cm Tape (50 Strips)

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : KFX

Prescription Use : Yes

Device Count : 1

VascuTape Radiopaque Tape - 00840663100354 Catalog Number : 1102-00

Device Description : Lemaitre Stent Guide (100 Strips)

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : KFX

Prescription Use : Yes

Device Count : 1

VascuTape Radiopaque Tape - 00840663100361 Catalog Number : 1102-20

Device Description : LeMaitre Stent Guide (20 Strips)

Device Class : 2

Duns Number: 184805166

Premarket Exempt : No

Product Code : KFX

Prescription Use : Yes

Device Count : 1

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