ALPHA MEDICAL INSTRUMENTS

Address:23455 Madero Ste B,MISSION VIEJO,CA,92691,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, Intravascular, Diagnostic (DQO) (10)

Premarket Exempt

Clear

Wedge Pressure 4fr 60cm Modified J-tip - M82214260P2 Catalog Number : 142-60P

Device Description : Wedge Pressure Balloon Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Wedge Pressure 5fr 110cm Modified J-tip(Standard-tip) - M822152110P0 Catalog Number : 152-110P

Device Description : Wedge Pressure Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Wedge Pressure 5fr 60cm Modified J-tip - M82215260P2 Catalog Number : 152-60P

Device Description : Wedge Pressure Balloon Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Wedge Pressure 6fr 110cm S-tip - M822162110PS0 Catalog Number : 162-110PS

Device Description : Wedge Pressure Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Wedge Pressure 6fr 110cm S-tip - M822162110PS2 Catalog Number : 162-110PS

Device Description : Wedge Pressure Balloon Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Wedge Pressure 6fr 110cm Standard Tip - M82216280P0 Catalog Number : 162-80P

Device Description : Wedge Pressure Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Wedge Pressure 6fr 80cm Modified J-tip - M82216280P2 Catalog Number : 162-80P

Device Description : Wedge Pressure Balloon Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Wedge Pressure 7fr 110cm S-tip - M822172110PS2 Catalog Number : 172-110PS

Device Description : Wedge Pressure Balloon Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Wedge Pressure 7fr 90cm Modified J-tip - M82217290P2 Catalog Number : 172-90P

Device Description : Wedge Pressure Balloon Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Angiographic 5fr 80cm C-tip - M82225280P2 Catalog Number : 252-80P

Device Description : Angiographic Balloon Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

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