Alliant Enterprises, LLC

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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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (2) Lavage, Jet (FQH) (1)

Premarket Exempt

No Yes

Clear

Surge Cardiovascular - 00817278011979 Catalog Number : 213-028

Device Description : Vein Graft Cannula-Blunt Tip w/Luer Extension

Device Class : 2

Duns Number: 121170653

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Surge Cardiovascular - 00817278011986 Catalog Number : 213-0252

Device Description : Vein graft cannula, blunt tip, free-flow (2 pack)

Device Class : 2

Duns Number: 121170653

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

Terumo Cardiovascular Systems - 00817278012396 Catalog Number : T402210

Device Description : BlowMister

Device Class : 2

Duns Number: 121170653

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : Yes

Device Count : 1

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