APPLIED MEDICAL RESOURCES CORPORATION

Address:22872 AVENIDA EMPRESA,RANCHO SANTA MARGARITA,CA,92688,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, Embolectomy (DXE) (7) Catheter, Biliary, Diagnostic (FGE) (3)

Premarket Exempt

No Yes

Clear

Syntel Thrombectomy Catheter - 00607915110956 Catalog Number :

Device Description : Embolectomy/thrombectomy balloon catheter

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Syntel Thrombectomy Catheter - 00607915110963 Catalog Number :

Device Description : Embolectomy/thrombectomy balloon catheter

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Syntel® Biliary Catheters - 00607915110987 Catalog Number :

Device Description : Used for the removal of stones and ductal debris from the biliary system.

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Syntel® Biliary Catheters - 00607915110994 Catalog Number :

Device Description : Used for the removal of stones and ductal debris from the biliary system.

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Syntel® Biliary Catheters - 00607915111007 Catalog Number :

Device Description : Used for the removal of stones and ductal debris from the biliary system.

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Syntel Embolectomy Catheter (Spring Tip) - 00607915111038 Catalog Number :

Device Description : Embolectomy/thrombectomy balloon catheter

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Syntel Embolectomy Catheter (Spring Tip) - 00607915111045 Catalog Number :

Device Description : Embolectomy/thrombectomy balloon catheter

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Syntel Embolectomy Catheter (Spring Tip) - 00607915111052 Catalog Number :

Device Description : Embolectomy/thrombectomy balloon catheter

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Syntel Embolectomy Catheter (Spring Tip) - 00607915111069 Catalog Number :

Device Description : Embolectomy/thrombectomy balloon catheter

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Syntel Embolectomy Catheter (Spring Tip) - 00607915111076 Catalog Number :

Device Description : Embolectomy/thrombectomy balloon catheter

Device Class : 2

Duns Number: 187129135

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

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