REFLOW MEDICAL, INC.

Address:208 Avenida Fabricante,San Clemente,CA,92672,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, Percutaneous (DQY) (10)

Premarket Exempt

Clear

SPEX35 - 00856492005111 Catalog Number : SPX35135US

Device Description : Spex Shapeable Support Catheter, 35X135cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

SPEX35 - 00856492005128 Catalog Number : SPX35090US

Device Description : Spex Shapeable Support Catheter, 35X90cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

SPEX35 - 00856492005135 Catalog Number : SPX35050US

Device Description : Spex Shapeable Support Catheter, 35X50cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

WINGMAN14 - 00856492005142 Catalog Number : WGM14150US

Device Description : Wingman Crossing Catheter, 14X150cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

WINGMAN14 - 00856492005159 Catalog Number : WGM14135US

Device Description : Wingman Crossing Catheter, 14X135cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

WINGMAN35 - 00856492005166 Catalog Number : WGM35135US

Device Description : Wingman Crossing Catheter, 35X135cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

WINGMAN35 - 00856492005173 Catalog Number : WGM35090US

Device Description : Wingman Crossing Catheter, 35X90cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

WINGMAN35 - 00856492005180 Catalog Number : WGM35065US

Device Description : Wingman Crossing Catheter, 35X65cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

WINGMAN14 - 00856492005197 Catalog Number : WGM14065US

Device Description : Wingman Crossing Catheter, 14X65cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

WINGMAN18 - 00856492005234 Catalog Number : WGM18090US

Device Description : Wingman Crossing Catheter, 18X90cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

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