CATHERA, INC.

CATHERA, INC.

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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 Flush (KRA) (10) Catheter, Percutaneous (DQY) (10)

Premarket Exempt

No

Clear

Phenom™ Catheter - 00814584020381 Catalog Number : FG11150-0615-2S

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584020398 Catalog Number : FG11150-1015-2S

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584020435 Catalog Number : FG11170-0615-2S

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584020442 Catalog Number : FG11170-1015-2S

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584020862 Catalog Number : FG11150-0615-2X

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584020879 Catalog Number : FG11150-1015-2X

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584020916 Catalog Number : FG11170-0615-2X

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584020923 Catalog Number : FG11170-1015-2X

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584021340 Catalog Number : FG11150-0615-2R

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

Phenom™ Catheter - 00814584021357 Catalog Number : FG11150-1015-2R

Device Description : Phenom™ 17 Catheter

Device Class : 2

Duns Number: 080116681

Premarket Exempt : No

Product Code : KRA, DQY

Prescription Use : Yes

Device Count : 1

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