CARDIOFOCUS, INC.

CARDIOFOCUS, INC.

Address:500 NICKERSON ROAD,Marlboro,MA,01752,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 fibrillation (OAE) (9) CATHETER, STEERABLE (DRA) (1) INTRODUCER, CATHETER (DYB) (1)

Premarket Exempt

No

Clear

HeartLight - 00859373007433 Catalog Number : 18-5000

Device Description : HeartLight X3 Disposable Motor Catheter

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

HeartLight - 00859373007440 Catalog Number : 18-4952

Device Description : HeartLight X3 Console, US

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

HeartLight - 00859373007464 Catalog Number : 18-4957

Device Description : HeartLight X3 Console, EU

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

HeartLight - 00859373007495 Catalog Number : 18-5033

Device Description : HeartLight X3 Console, JP

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

HeartLight - 00868976000109 Catalog Number : 18-2531-N250

Device Description : Laser Ablation Balloon Catheter

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

HeartLight - 00868976000116 Catalog Number : 18-2959

Device Description : Endoscopic Ablation Console (EU)

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

HeartLight - 00868976000123 Catalog Number : 18-1447

Device Description : Endoscope

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

HeartLight - 00868976000130 Catalog Number : 18-1342

Device Description : Balloon Fill Media

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

HeartLight - 00868976000147 Catalog Number : 18-3356

Device Description : Deflectable Sheath

Device Class : 2

Duns Number: 068966261

Premarket Exempt : No

Product Code : DRA, DYB

Prescription Use : Yes

Device Count : 1

HeartLight - 00868976000154 Catalog Number : 18-3055

Device Description : Laser Ablation Console

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

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