HANSEN MEDICAL, INC.

Address:3527 Combine Street,PASO ROBLES,CA,93446,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, Steerable (DRA) (6) System, Catheter Control, Steerable (DXX) (4)

Premarket Exempt

No Yes

Clear

Magellan™ - 00815671020017 Catalog Number : MC9F50

Device Description : Magellan Robotic Catheter 9Fr 50cm

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DRA

Prescription Use : Yes

Device Count : 1

Magellan™ - 00815671020024 Catalog Number : MC9F65

Device Description : Magellan Robotic Catheter 9Fr 65cm

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DRA

Prescription Use : Yes

Device Count : 1

Magellan™ - 00815671020031 Catalog Number : MC9F80

Device Description : Magellan Robotic Catheter 9Fr 80cm

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DRA

Prescription Use : Yes

Device Count : 1

Magellan™ - 00815671020048 Catalog Number : MACC50

Device Description : Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 50cm

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DXX

Prescription Use : Yes

Device Count : 1

Magellan™ - 00815671020055 Catalog Number : MACC65

Device Description : Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 65cm

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DXX

Prescription Use : Yes

Device Count : 1

Magellan™ - 00815671020062 Catalog Number : MACC80

Device Description : Magellan Robotic Catheter 9Fr & 10Fr Accessory Kit 80cm

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DXX

Prescription Use : Yes

Device Count : 1

Magellan™ - 00815671020079 Catalog Number : MRCCAD

Device Description : Magellan Robotic Catheter 9Fr & 10Fr Caddy

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DXX

Prescription Use : Yes

Device Count : 1

Artisan Extend® - 00815671020109 Catalog Number : 12412

Device Description : Artisan Extend Control Catheter

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DRA

Prescription Use : Yes

Device Count : 1

Magellan™ - 00815671020116 Catalog Number : MC6F60

Device Description : Magellan Robotic Catheter 6Fr Guide 60cm

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DRA

Prescription Use : Yes

Device Count : 1

Magellan™ - 00815671020123 Catalog Number : MC6F95

Device Description : Magellan Robotic Catheter 6Fr Guide 95cm

Device Class : 2

Duns Number: 128941304

Premarket Exempt : No

Product Code : DRA

Prescription Use : Yes

Device Count : 1

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