AV MEDICAL TECHNOLOGIES LTD

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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) (7) Catheter, Continuous Flush (KRA) (7)

Premarket Exempt

Clear

chameleon - 07290016745016 Catalog Number : CH05-40-75US

Device Description : Chameleon PTA Balloon Dilatation Catheter 5x40 mm

Device Class : 2

Duns Number: 600459882

Premarket Exempt : No

Product Code : LIT, KRA

Prescription Use : Yes

Device Count : 1

Chameleon - 07290016745023 Catalog Number : CH06-40-75US

Device Description : Chameleon PTA Balloon Dilatation Catheter 6x40 mm

Device Class : 2

Duns Number: 600459882

Premarket Exempt : No

Product Code : LIT, KRA

Prescription Use : Yes

Device Count : 1

Chameleon - 07290016745030 Catalog Number : CH07-40-75US

Device Description : Chameleon PTA Balloon Dilatation Catheter 7x40 mm

Device Class : 2

Duns Number: 600459882

Premarket Exempt : No

Product Code : LIT, KRA

Prescription Use : Yes

Device Count : 1

Chameleon - 07290016745047 Catalog Number : CH08-40-75US

Device Description : Chameleon PTA Balloon Dilatation Catheter 8x40 mm

Device Class : 2

Duns Number: 600459882

Premarket Exempt : No

Product Code : LIT, KRA

Prescription Use : Yes

Device Count : 1

Chameleon - 07290016745054 Catalog Number : CH09-40-75US

Device Description : Chameleon PTA Balloon Dilatation Catheter 9x40 mm

Device Class : 2

Duns Number: 600459882

Premarket Exempt : No

Product Code : KRA, LIT

Prescription Use : Yes

Device Count : 1

Chameleon - 07290016745061 Catalog Number : CH10-40-75US

Device Description : Chameleon PTA Balloon Dilatation Catheter 10x40 mm

Device Class : 2

Duns Number: 600459882

Premarket Exempt : No

Product Code : LIT, KRA

Prescription Use : Yes

Device Count : 1

Chameleon - 07290016745085 Catalog Number : CH12-40-75US

Device Description : Chameleon PTA Balloon Dilatation Catheter 12x40 mm

Device Class : 2

Duns Number: 600459882

Premarket Exempt : No

Product Code : KRA, LIT

Prescription Use : Yes

Device Count : 1

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