ARGON MEDICAL DEVICES, INC.

Address:1445 FLAT CREEK RD.,ATHENS,TX,75751,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, Continuous Irrigation (GBQ) (8) Wire, Guide, Catheter (DQX) (2)

Premarket Exempt

No Yes

Clear

SKATER™ Drainage Catheter - 00886333000203 Catalog Number : 755112035

Device Description : SKATER™ Drainage Catheter - locking pigtail 12F x 35cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Single Step Drainage Set - 00886333000227 Catalog Number : 756006025

Device Description : SKATER™ Single Step Drainage Set 6Fr x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Single Step Drainage Set - 00886333000241 Catalog Number : 756007025

Device Description : SKATER™ Single Step Drainage Set 7Fr x 25cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Single Step Drainage Set - 00886333000258 Catalog Number : 756008020

Device Description : SKATER™ Single Step Drainage Set 8F x 20cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Single Step Drainage Set - 00886333000272 Catalog Number : 756010020

Device Description : SKATER™ Single Step Drainage Set 10Fr x 20cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Single Step Drainage Set - 00886333000296 Catalog Number : 756012020

Device Description : SKATER™ Single Step Drainage Set 12Fr x 20cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Single Step Drainage Set - 00886333000388 Catalog Number : 756510020

Device Description : SKATER™ Single Step Drainage Set - Locking 10F x 20cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

SKATER™ Single Step Drainage Set - 00886333000418 Catalog Number : 756512020

Device Description : SKATER™ Single Step Drainage Set - Locking 12F x 20cm

Device Class : 1

Duns Number: 140727624

Premarket Exempt : Yes

Product Code : GBQ

Prescription Use : Yes

Device Count : 1

POINTER™ Nitinol Guidewire - 00886333000739 Catalog Number : 180418210

Device Description : POINTER™ Nitinol Guidewire 0.018"/210cm/40mm

Device Class : 2

Duns Number: 140727624

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

POINTER™ Nitinol Guidewire - 00886333000746 Catalog Number : 180418260

Device Description : POINTER™ Nitinol Guidewire 0.018"/260cm/40mm

Device Class : 2

Duns Number: 140727624

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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