ACIST MEDICAL SYSTEMS, INC.

Address:7905 FULLER ROAD,EDEN PRAIRIE,MN,55344,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

Injector And Syringe, Angiographic (DXT) (8) Transducer, Pressure, Catheter Tip (DXO) (2)

Premarket Exempt

Clear

ACIST Navvus® Catheter - 10841716100007 Catalog Number :

Device Description : Navvus Catheter, p/n 701481-002

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

ACIST Navvus® Catheter - 10841716100014 Catalog Number :

Device Description : Navvus Catheter, p/n 701481-003

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

A2000 Multi-use Syringe Kit - 10841716100021 Catalog Number :

Device Description : A2000 Multi-use Syringe Kit, p/n 701277-003Kit Contents: 100mL contrast reservoi A2000 Multi-use Syringe Kit, p/n 701277-003Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

A2000 Multi-use Syringe Kit - 10841716100038 Catalog Number :

Device Description : A2000 Multi-use Syringe Kit, p/n 700334-016Kit Contents: 100mL contrast reservoi A2000 Multi-use Syringe Kit, p/n 700334-016Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

A2000 Multi-use Syringe Kit - 10841716100045 Catalog Number :

Device Description : A2000 Multi-use Syringe Kit, p/n 700334-015Kit Contents: 100mL contrast reservoi A2000 Multi-use Syringe Kit, p/n 700334-015Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

A2000 Multi-use Syringe Kit - 10841716100052 Catalog Number :

Device Description : A2000 Multi-use Syringe Kit, p/n 700334-010Kit Contents: 100mL contrast reservoi A2000 Multi-use Syringe Kit, p/n 700334-010Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

A2000 Multi-use Syringe Kit - 10841716100069 Catalog Number :

Device Description : A2000 Multi-use Syringe Kit, p/n 700334-014Kit Contents: 100mL contrast reservoi A2000 Multi-use Syringe Kit, p/n 700334-014Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

ACIST CVi® Cart - 10841716100076 Catalog Number :

Device Description : CVi Cart, p/n 701351-001

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Multi-use Syringe Kit - 10841716100083 Catalog Number :

Device Description : Model A2000V, p/n 701259-003Kit Contents: 100mL contrast reservoir and tubing wi Model A2000V, p/n 701259-003Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100090 Catalog Number :

Device Description : Model AT L65, p/n 700608-026Kit Contents: hand controller, 3-way high-pressure s Model AT L65, p/n 700608-026Kit Contents: hand controller, 3-way high-pressure stopcock with rotating end and premium high-pressure tubing

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

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