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

SPEX18 - 00856492005340 Catalog Number : SPX18150US

Device Description : Spex Shapeable Support Catheter, 18X150cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

SPEX14 - 00856492005357 Catalog Number : SPX14090US

Device Description : Spex Shapeable Support Catheter, 14X90cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

SPEX14 - 00856492005364 Catalog Number : SPX14135US

Device Description : Spex Shapeable Support Catheter, 14X135cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

SPEX14 - 00856492005371 Catalog Number : SPX14150US

Device Description : Spex Shapeable Support Catheter, 14X150cm

Device Class : 2

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Spex LP - 00856492005630 Catalog Number :

Device Description : speX LP Shapeable Support Catheter, 14 X 90cm, US

Device Class :

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Spex LP - 00856492005647 Catalog Number :

Device Description : speX LP Shapeable Support Catheter, 14 X 135cm, US

Device Class :

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Spex LP - 00856492005654 Catalog Number :

Device Description : speX LP Shapeable Support Catheter, 14 X 150cm, US

Device Class :

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Spex LP - 00856492005661 Catalog Number :

Device Description : speX LP Shapeable Support Catheter, 18 X 90cm, US

Device Class :

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Spex LP - 00856492005678 Catalog Number :

Device Description : speX LP Shapeable Support Catheter, 18 X 135cm, US

Device Class :

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Spex LP - 00856492005685 Catalog Number :

Device Description : speX LP Shapeable Support Catheter, 18 X 150cm, US

Device Class :

Duns Number: 962545294

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

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