ANGIODYNAMICS, INC.

Address:603 QUEENSBURY AVE.,Queensbury,NY,12804,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

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR (LJT) (4) Catheter, cannula and tubing, vascular, cardiopulmonary bypass (DWF) (3) Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass (DTL) (1) Catheter, angioplasty, peripheral, transluminal (LIT) (1)

Premarket Exempt

No Yes

Clear

Vortex - H787P12105K0 Catalog Number :

Device Description : Lifeport Single Plastic Vascular Access Port System with Attached 9.6F x 76cm Si Lifeport Single Plastic Vascular Access Port System with Attached 9.6F x 76cm Silicone Catheter

Device Class : 2

Duns Number: 601994184

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

Vortex - H787P12155K0 Catalog Number :

Device Description : Lifeport Single Plastic Vascular Access Port System with Attachable 8.4F x 76cm Lifeport Single Plastic Vascular Access Port System with Attachable 8.4F x 76cm Polyurethane Catheter

Device Class : 2

Duns Number: 601994184

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

Vortex - H787P12305K0 Catalog Number :

Device Description : Vortex LP Single Titanium Port System with Attachable 9.6F x 76cm Silicone Catheter

Device Class : 2

Duns Number: 601994184

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

Vortex - H787P12355K0 Catalog Number :

Device Description : Vortex LP Low Profile Titanium Port System with Detached 8.4F and 9.6F x 76cm Si Vortex LP Low Profile Titanium Port System with Detached 8.4F and 9.6F x 76cm Silicone Catheters

Device Class : 2

Duns Number: 601994184

Premarket Exempt : No

Product Code : LJT

Prescription Use : Yes

Device Count : 1

AngioVac - H965251930 Catalog Number :

Device Description : AngioVac C20 with Obturator

Device Class :

Duns Number: 079105071

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

AngioVac - H965251940 Catalog Number :

Device Description : AngioVac C180 with Obturator

Device Class :

Duns Number: 079105071

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

AngioVac - H965252000 Catalog Number :

Device Description : AngioVac F18 85 Cannula

Device Class : 2

Duns Number: 079105071

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

NAMIC - H965800450750 Catalog Number :

Device Description : NEEDLE GUIDEWIRE INTRODUCER - OEM

Device Class : 2

Duns Number: 079105071

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

NAMIC - H965814001240 Catalog Number :

Device Description : Y-ADAPTOR,LG.BORE,FINE THREAD W/10" FLEXCIL EXT.-OEM

Device Class : 2

Duns Number: 079105071

Premarket Exempt : No

Product Code : DTL

Prescription Use : Yes

Device Count : 1

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