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) (7) Catheter, Pressure Monitoring, Cardiac (OBI) (2) Catheter, Ultrasound, Intravascular (OBJ) (1)

Premarket Exempt

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CPT2000 Automated Manifold Kit - 10841716100342 Catalog Number :

Device Description : Model CPT2000 p/n 701324-004Kit Contents: manifold with saline and contrast port Model CPT2000 p/n 701324-004Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

AngioTouch® Kit - 10841716100359 Catalog Number :

Device Description : Model AT P54, p/n 700608-052Kit Contents: hand controller, 3-way high-pressure s Model AT P54, p/n 700608-052Kit 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

ACIST RXi® Bed Rail Mount - 10841716100588 Catalog Number :

Device Description : RXi Bed Rail Mount, p/n 701605-001

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : OBI

Prescription Use : Yes

Device Count : 1

ACIST RXi® Cart - 10841716100595 Catalog Number :

Device Description : RXi Cart, p/n 701606-001

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : OBI

Prescription Use : Yes

Device Count : 1

ACIST CVi® Angiographic Injection System Injector Head - 10841716100601 Catalog Number :

Device Description : CVi Injector, p/n 700706-008

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

ACIST CVi® Angiographic Injection System Injector Head - 10841716100618 Catalog Number :

Device Description : CVi Injector (Siemens), p/n 700708-008

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

ACIST CVi® Angiographic Injection System Control Panel - 10841716100625 Catalog Number :

Device Description : CVi Angiographic Injection System Control Panel, p/n 700771-005

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

ACIST CVi® Angiographic Injection System Power Supply - 10841716100632 Catalog Number :

Device Description : CVi Power Supply p/n 701340-002

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

BT2000 Automated Manifold Kit - 10841716100649 Catalog Number :

Device Description : Model BT2000 p/n 700287-021Kit Contents: manifold with saline and contrast ports Model BT2000 p/n 700287-021Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

ACIST HDi® Linear Translation System (LTS) - 10841716100694 Catalog Number :

Device Description : HDi LTS, p/n 701457-004

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : OBJ

Prescription Use : Yes

Device Count : 1

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