CARDIOFOCUS, INC.

CARDIOFOCUS, INC.

Address:500 NICKERSON ROAD,Marlboro,MA,01752,US

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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) (2)

Premarket Exempt

No

Clear

HeartLight - 00868976000161 Catalog Number : 18-4247

Device Description : Endoscopic Ablation Console (JP)

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

HeartLight - 00868976000178 Catalog Number : 18-4000-27A

Device Description : Endoscopic Ablation Catheter

Device Class : 3

Duns Number: 068966261

Premarket Exempt : No

Product Code : OAE

Prescription Use : Yes

Device Count : 1

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