CARDIOMEMS, INC.

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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

System, hemodynamic, implantable (MOM) (6) WIRE, GUIDE, CATHETER (DQX) (1)

Premarket Exempt

Clear

CardioMEMS™ - 05414734509169 Catalog Number : CM1000

Device Class : 3

Duns Number: 086938409

Premarket Exempt : No

Product Code : MOM

Prescription Use : Yes

Device Count : 1

CardioMEMS™ - 05414734509176 Catalog Number : CM1010

Device Class : 3

Duns Number: 086938409

Premarket Exempt : No

Product Code : MOM

Prescription Use : Yes

Device Count : 1

CardioMEMS™ - 05414734509237 Catalog Number : CM2000

Device Description : PA Sensor and Delivery System

Device Class : 3

Duns Number: 086938409

Premarket Exempt : No

Product Code : MOM

Prescription Use : Yes

Device Count : 1

CardioMEMS™ - 05414734509244 Catalog Number : CM3000

Device Class : 3

Duns Number: 086938409

Premarket Exempt : No

Product Code : MOM

Prescription Use : Yes

Device Count : 1

CardioMEMS™ - 05414734509565 Catalog Number : CM2010

Device Description : 0.018 in / 260 cm

Device Class : 2

Duns Number: 086938409

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

CardioMEMS™ - 05414734509800 Catalog Number : CM1100

Device Description : Patient Electronics System

Device Class : 3

Duns Number: 086938409

Premarket Exempt : No

Product Code : MOM

Prescription Use : Yes

Device Count : 1

CardioMEMS™ - 05415067029331 Catalog Number : CM3000

Device Description : Hospital Electronics System

Device Class : 3

Duns Number: 086938409

Premarket Exempt : No

Product Code : MOM

Prescription Use : Yes

Device Count : 1

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