SUREFIRE MEDICAL, INC.

Address:6272 W 91st Ave,Westminster,CO,80031,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, Intravascular, Diagnostic (DQO) (7) Catheter, Percutaneous (DQY) (3)

Premarket Exempt

No Yes

Clear

Surefire Infusion System - 00857136004019 Catalog Number :

Device Description : 120cm, 3.8F Microcatheter with 7.5mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Surefire Infusion System - 00857136004040 Catalog Number :

Device Description : 120cm, 3.8F Microcatheter with 5mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Surefire Guiding Catheter - 00857136004057 Catalog Number :

Device Description : 65cm, 5F Guiding Catheter with Cobra1 Shape

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Surefire Guiding Catheter - 00857136004064 Catalog Number :

Device Description : 65cm. 5F Guiding Catheter with Sim1 Shape

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Surefire Guiding Catheter - 00857136004071 Catalog Number :

Device Description : 65cm, 5F Guiding Catheter with Axis Shape

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Surefire Precision Infusion System - 00857136004088 Catalog Number :

Device Description : 120cm, 0.021" Microcatheter with 3.5mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Surefire Precision Infusion System - 00857136004095 Catalog Number :

Device Description : 150cm 0.021" Microcatheter w/ 3.5mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Surefire Precision Infusion System - 00857136004101 Catalog Number :

Device Description : 120cm 0.025" Microcatheter w/ 5mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Surefire Precision Infusion System - 00857136004118 Catalog Number :

Device Description : 120cm 0.025" Microcatheter w/ 7mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

Surefire Precision Infusion System - 00857136004125 Catalog Number :

Device Description : 150cm 0.025" Microcatheter w/ 7mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

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