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) (9) Catheter, Ultrasound, Intravascular (OBJ) (1)

Premarket Exempt

Clear

AngioTouch® Kit - 10841716100243 Catalog Number :

Device Description : Model AT R54, p/n 700608-025Kit Contents: hand controller, 3-way high-pressure s Model AT R54, p/n 700608-025Kit 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 HDi® System Console - 10841716100250 Catalog Number :

Device Description : HDi System Console, p/n 701460-004

Device Class : 2

Duns Number: 926684994

Premarket Exempt : No

Product Code : OBJ

Prescription Use : Yes

Device Count : 1

B2000 Automated Manifold Kit - 10841716100267 Catalog Number :

Device Description : Model B2000 p/n 700303-011Kit Contents: manifold with saline and contrast ports, Model B2000 p/n 700303-011Kit 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

BT2000 Automated Manifold Kit - 10841716100274 Catalog Number :

Device Description : Model BT2000 p/n 700287-012Kit Contents: manifold with saline and contrast ports Model BT2000 p/n 700287-012Kit 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

BT2000 Automated Manifold Kit - 10841716100281 Catalog Number :

Device Description : Model BT2000 p/n 700287-013Kit Contents: manifold with saline and contrast ports Model BT2000 p/n 700287-013Kit 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

BT2000 Automated Manifold Kit - 10841716100298 Catalog Number :

Device Description : Model BT2000 p/n 700287-016Kit Contents: manifold with saline and contrast ports Model BT2000 p/n 700287-016Kit 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

BT2000 Automated Manifold Kit - 10841716100304 Catalog Number :

Device Description : Model BT2000 p/n 700287-017Kit Contents: manifold with saline and contrast ports Model BT2000 p/n 700287-017Kit Contents: manifold with saline and contrast ports, saline tubing with spike and hand syringe, transducer

Device Class :

Duns Number: 926684994

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

BT2000 Automated Manifold Kit - 10841716100311 Catalog Number :

Device Description : Model BT2000 p/n 701279-002Kit Contents: manifold with saline and contrast ports Model BT2000 p/n 701279-002Kit 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

BT2000 Automated Manifold Kit - 10841716100328 Catalog Number :

Device Description : Model BT2000 p/n 701279-004Kit Contents: manifold with saline and contrast ports Model BT2000 p/n 701279-004Kit 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

CPT2000 Automated Manifold Kit - 10841716100335 Catalog Number :

Device Description : Model CPT2000 p/n 701324-002Kit Contents: manifold with saline and contrast port Model CPT2000 p/n 701324-002Kit 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

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