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) (6) Catheter, Percutaneous (DQY) (2) Stand, Infusion (FOX) (1)

Premarket Exempt

No Yes

Clear

Surefire Precision Infusion System - 00857136004132 Catalog Number :

Device Description : 150cm 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 Flexion Guiding Catheter - 00857136004149 Catalog Number :

Device Description : 80cm, 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 Flexion Guiding Catheter - 00857136004156 Catalog Number :

Device Description : 80cm, 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 Spark Infusion System - 00857136004163 Catalog Number :

Device Description : 150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

SIS Adaptor - 00857136004170 Catalog Number :

Device Description : Surefire Infusion System Adaptor

Device Class : 1

Duns Number: 832575497

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

Surefire Spark Infusion System - 00857136004187 Catalog Number :

Device Description : 120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

TriSalus Infusion System - 00857136004194 Catalog Number :

Device Description : 120cm, 0.021" Microcatheter with 6mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

TriNav Infusion System - 00857136004200 Catalog Number :

Device Description : 150cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

TriNav Infusion System - 00857136004217 Catalog Number :

Device Description : 120cm 0.021" Microcatheter w/ 1.5-3.5mm Expandable Tip

Device Class : 2

Duns Number: 832575497

Premarket Exempt : No

Product Code : DQO

Prescription Use : Yes

Device Count : 1

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