CLEARSTREAM TECHNOLOGIES LIMITED

Address:Moyne Upper,Wexford,IE

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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, angioplasty, peripheral, transluminal (LIT) (10)

Premarket Exempt

Clear

Sleek PTA Dilatation Catheter - 00801741132520 Catalog Number : 425-3510X

Device Description : Sleek PTA Dilatation Catheter 3.5mm x 100mm balloon, 150cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Sleek PTA Dilatation Catheter - 00801741132537 Catalog Number : 425-3512X

Device Description : Sleek PTA Dilatation Catheter 3.5mm x 120mm balloon, 150cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Sleek PTA Dilatation Catheter - 00801741132544 Catalog Number : 425-3515X

Device Description : Sleek PTA Dilatation Catheter 3.5mm x 150mm balloon, 155cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Sleek PTA Dilatation Catheter - 00801741132551 Catalog Number : 425-3518X

Device Description : Sleek PTA Dilatation Catheter 3.5mm x 180mm balloon, 155cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Sleek PTA Dilatation Catheter - 00801741132568 Catalog Number : 425-3522X

Device Description : Sleek PTA Dilatation Catheter 3.5mm x 220mm balloon, 155cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Sleek PTA Dilatation Catheter - 00801741132575 Catalog Number : 425-4004X

Device Description : Sleek PTA Dilatation Catheter 4.0mm x 40mm balloon, 150cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Sleek PTA Dilatation Catheter - 00801741132582 Catalog Number : 425-4006X

Device Description : Sleek PTA Dilatation Catheter 4.0mm x 60mm balloon, 150cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Sleek PTA Dilatation Catheter - 00801741132599 Catalog Number : 425-4008X

Device Description : Sleek PTA Dilatation Catheter 4.0mm x 80mm balloon, 150cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Sleek PTA Dilatation Catheter - 00801741132605 Catalog Number : 425-4010X

Device Description : Sleek PTA Dilatation Catheter 4.0mm x 100mm balloon, 150cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Sleek PTA Dilatation Catheter - 00801741132612 Catalog Number : 425-4012X

Device Description : Sleek PTA Dilatation Catheter 4.0mm x 120mm balloon, 150cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

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