Q'APEL MEDICAL LLC

Address:46708 Lakeview Blvd,Fremont,CA,94538,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, Percutaneous (DQY) (7) Catheter, Percutaneous, Neurovasculature (QJP) (4) Catheter, Intravascular Occluding, Temporary (MJN) (2)

Premarket Exempt

Clear

Wahoo - 00857545008004 Catalog Number : SF7072-105

Device Description : SelectFlex 072 Neurovascular Access System, 105cm

Device Class : 2

Duns Number: 020937374

Premarket Exempt : No

Product Code : DQY

Prescription Use : No

Device Count : 1

Walrus - 00857545008011 Catalog Number : BG8087-090

Device Description : 087 Balloon Guide Catheter System, 90cm

Device Class : 2

Duns Number: 020937374

Premarket Exempt : No

Product Code : DQY, MJN

Prescription Use : No

Device Count : 1

Walrus - 00857545008028 Catalog Number : BG8087-095

Device Description : 087 Balloon Guide Catheter System, 95cm

Device Class : 2

Duns Number: 020937374

Premarket Exempt : No

Product Code : DQY, MJN

Prescription Use : No

Device Count : 1

Armadillo - 00857545008042 Catalog Number : SF7072-105-22-30

Device Description : SelectFlex II 072 Neurovascular Access System 105cm, 22cm Variable Stiffness, 30cm Coating

Device Class : 2

Duns Number: 020937374

Premarket Exempt : No

Product Code : DQY, QJP

Prescription Use : No

Device Count : 1

Armadillo - 00857545008059 Catalog Number : SF7072-95-22-30

Device Description : SelectFlex II 072 Neurovascular Access System 95cm, 22cm Variable Stiffness, 30cm Coating

Device Class : 2

Duns Number: 020937374

Premarket Exempt : No

Product Code : DQY, QJP

Prescription Use : No

Device Count : 1

Armadillo - 00857545008066 Catalog Number : SF7072-95-27-30

Device Description : SelectFlex II 072 Neurovascular Access System 95cm, 27cm Variable Stiffness, 30cm Coating

Device Class : 2

Duns Number: 020937374

Premarket Exempt : No

Product Code : DQY, QJP

Prescription Use : No

Device Count : 1

Armadillo - 00857545008073 Catalog Number : SF7072-105-27-30

Device Description : SelectFlex II 072 Neurovascular Access System 105cm, 27cm Variable Stiffness, 30cm Coating

Device Class : 2

Duns Number: 020937374

Premarket Exempt : No

Product Code : DQY, QJP

Prescription Use : No

Device Count : 1

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