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 - 00801741132629 Catalog Number : 425-4015X

Device Description : Sleek PTA Dilatation Catheter 4.0mm 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 - 00801741132636 Catalog Number : 425-4018X

Device Description : Sleek PTA Dilatation Catheter 4.0mm 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 - 00801741132643 Catalog Number : 425-4022X

Device Description : Sleek PTA Dilatation Catheter 4.0mm x 220mm balloon, 155cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Savvy Long PTA Dilatation Catheter - 00801741132650 Catalog Number : 436-2012L

Device Description : Savvy Long PTA Dilatation Catheter 2.0mm x 120mm balloon, 120cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Savvy Long PTA Dilatation Catheter - 00801741132667 Catalog Number : 436-2012S

Device Description : Savvy Long PTA Dilatation Catheter 2.0mm x 120mm balloon, 80cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Savvy Long PTA Dilatation Catheter - 00801741132674 Catalog Number : 436-2012X

Device Description : Savvy Long PTA Dilatation Catheter 2.0mm x 120mm balloon, 150cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Savvy Long PTA Dilatation Catheter - 00801741132681 Catalog Number : 436-2015L

Device Description : Savvy Long PTA Dilatation Catheter 2.0mm x 150mm balloon, 120cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Savvy Long PTA Dilatation Catheter - 00801741132698 Catalog Number : 436-2015S

Device Description : Savvy Long PTA Dilatation Catheter 2.0mm x 150mm balloon, 80cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Savvy Long PTA Dilatation Catheter - 00801741132704 Catalog Number : 436-2015X

Device Description : Savvy Long PTA Dilatation Catheter 2.0mm x 150mm balloon, 150cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

Savvy Long PTA Dilatation Catheter - 00801741132711 Catalog Number : 436-2018L

Device Description : Savvy Long PTA Dilatation Catheter 2.0mm x 180mm balloon, 120cm shaft

Device Class : 2

Duns Number: 989214291

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

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