IRVINE BIOMEDICAL, INC.

Address:2375 Morse Ave,IRVINE,CA,92614,US

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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, percutaneous, cardiac ablation, for treatment of atrial flutter (OAD) (4)

Premarket Exempt

No Yes

Clear

Therapy™ - 05415067004567 Catalog Number : A700456

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 926346966

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Therapy™ - 05415067004574 Catalog Number : A700457

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 926346966

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Cool Point™ - 05415067008985 Catalog Number : IBI-89003

Device Description : Irrigation Pump

Device Class : 3

Duns Number: 926346966

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Therapy™ - 05415067019875 Catalog Number : IBI-84312

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 926346966

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

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