ROUTE 92 MEDICAL

Address:155 Bovet Road,San Mateo,CA,94402,US

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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, Percutaneous, Neurovasculature (QJP) (5) Catheter, Percutaneous (DQY) (2)

Premarket Exempt

Clear

Full Length 088 Catheter, 132 cm - 00853799007060 Catalog Number :

Device Description : Full Length 088 Catheter, 132 cm

Device Class : 2

Duns Number: 067429673

Premarket Exempt : No

Product Code : QJP

Prescription Use : Yes

Device Count : 1

Full Length 088 x 132cm Access System - 00853799007138 Catalog Number : REF 4002

Device Description : Full Length 088 x 132cm Access System; Contains Tenzing 8 Delivery Catheter (008 Full Length 088 x 132cm Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and Full Length 088 Catheter, 132cm (00853799007060)

Device Class : 2

Duns Number: 067429673

Premarket Exempt : No

Product Code : QJP

Prescription Use : Yes

Device Count : 1

Tenzing 7 Delivery Catheter - 00853799007237 Catalog Number : REF 1005

Device Description : Tenzing 7 Delivery Catheter

Device Class : 2

Duns Number: 067429673

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

088 Access System - 00853799007275 Catalog Number : REF 2004

Device Description : 088 Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and 088 088 Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and 088 Catheter (00853799007282)

Device Class : 2

Duns Number: 067429673

Premarket Exempt : No

Product Code : QJP

Prescription Use : Yes

Device Count : 1

088 Catheter - 00853799007282 Catalog Number :

Device Description : 088 Catheter

Device Class : 2

Duns Number: 067429673

Premarket Exempt : No

Product Code : QJP

Prescription Use : Yes

Device Count : 1

Tenzing 8 Delivery Catheter - 00853799007299 Catalog Number :

Device Description : Tenzing 8 Delivery Catheter

Device Class : 2

Duns Number: 067429673

Premarket Exempt : No

Product Code : QJP

Prescription Use : Yes

Device Count : 1

8F Base Camp Sheath System - 00853799007404 Catalog Number : REF 5001

Device Description : 8F Base Camp Sheath System

Device Class : 2

Duns Number: 067429673

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

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