KALILA MEDICAL, INC.

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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

INTRODUCER, CATHETER (DYB) (3) Introducer, Catheter (DYB) (2)

Premarket Exempt

Clear

Vado - 00810591020215 Catalog Number : SS8FMU67

Device Description : Steerable Sheath, Unidirectional (140 degrees)

Device Class : 2

Duns Number: 015986592

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Vado - 00810591020222 Catalog Number : SS8FMB74

Device Description : Steerable Sheath, Bidirectional

Device Class : 2

Duns Number: 015986592

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Vado - 00810591020239 Catalog Number : SS8FMU67

Device Description : Steerable Sheath, Unidirectional (200 degrees)

Device Class : 2

Duns Number: 015986592

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

CrossWise - 00850021246082 Catalog Number :

Device Description : Steerable Transseptal Sheath

Device Class : 2

Duns Number: 015986592

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Nagare - 00861705000425 Catalog Number :

Device Description : Steerable Sheath, Bi-Directional

Device Class : 2

Duns Number: 015986592

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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