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) (6) CABLE, ELECTRODE (IKD) (2) CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING (DRF) (2)

Premarket Exempt

No Yes

Clear

SJM™ - 05414734309332 Catalog Number : IBI-85954

Device Class : 2

Duns Number: 926346966

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

SJM™ - 05414734309349 Catalog Number : IBI-85955

Device Class : 2

Duns Number: 926346966

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Inquiry™ - 05414734309912 Catalog Number : IBI-87007

Device Description : Diagnostic Catheter

Device Class : 2

Duns Number: 926346966

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Inquiry™ - 05414734309929 Catalog Number : IBI-87008

Device Description : Diagnostic Catheter

Device Class : 2

Duns Number: 926346966

Premarket Exempt : No

Product Code : DRF

Prescription Use : Yes

Device Count : 1

Therapy™ - 05414734310659 Catalog Number : A088046

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 926346966

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Therapy™ - 05414734310666 Catalog Number : A088047

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 926346966

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Therapy™ - 05414734310673 Catalog Number : A088048

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 926346966

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Therapy™ - 05414734310680 Catalog Number : A088049

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 926346966

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Safire™ Blu™ SP - 05414734310734 Catalog Number : A402869

Device Description : Ablation Catheter

Device Class : 3

Duns Number: 926346966

Premarket Exempt : No

Product Code : OAD

Prescription Use : Yes

Device Count : 1

Safire™ Blu™ SP - 05414734310741 Catalog Number : A402871

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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