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Sign in to claim this brandCardiomems, Inc.
US
Last updated May 27, 2026
What Cardiomems, Inc. makes
Cardiomems, Inc. manufactures implantable pulmonary artery pressure monitoring systems, including wireless sensors for continuous hemodynamic monitoring in heart failure patients. The company also produces single-use cardiac and peripheral vascular guidewires for procedural support.
The portfolio includes devices classified as Class II and Class III under US regulations, with authorisations recorded via FDA 510(k) and Unique Device Identifier (UDI) listings. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Cardiomems, Inc. manufacture?
Cardiomems, Inc. specializes in two primary categories of medical devices: implantable pulmonary artery pressure monitoring systems and single-use cardiac/peripheral vascular guidewires. The most prominent product is a wireless sensor system designed for continuous monitoring of hemodynamic pressures in patients with heart failure. The guidewires support interventional procedures in cardiac and vascular care.
Where is Cardiomems, Inc. based?
Cardiomems, Inc. is headquartered in the United States. The company’s location influences its regulatory compliance with US medical device standards, including FDA requirements for device classification and authorisation.
Which regulatory registries or databases list Cardiomems, Inc.’s devices?
Cardiomems, Inc.’s devices are recorded in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track devices classified as Class II and Class III under US regulations, ensuring transparency for healthcare providers and regulators.
How are Cardiomems, Inc.’s devices classified under US regulations?
Cardiomems, Inc.’s devices fall into two regulatory classes: Class II and Class III. Class II devices generally pose moderate risk and require special controls beyond general controls, while Class III devices are high-risk and typically require premarket approval due to insufficient data from less stringent classifications. The company’s portfolio includes both types, reflecting varying levels of monitoring and procedural support.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sjm.com
- —
- —
- [email protected]
- Phone
- +1(855)478-5833
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 086938409
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CardioMEMS™ | Guidewire | FDA UDI | Class II | Active |
| CardioMEMS™ | CM3120 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM3150 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM2000 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM1100 | FDA UDI | Class III | Active |
| Merlin.net | MN6000 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM3020 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM1000 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM3040 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM1060 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM3100 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM3000 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM1010 | FDA UDI | Class III | Active |
| CardioMEMS™ | CM3000 | FDA UDI | Class III | Active |
| Cardiomems Endosensor With Delivery System And Endosensor Electronics System | DEN050006 | FDA 510(k) | Class II | Active |
| Cardiomems Endosure Wireless Aaa Pressure Measurement System, Model Ads-1001 | K070448 | FDA 510(k) | Class II | Active |
| Cardiomems Endosure S2 14f Wireless Aaa Pressure Measurement System, Model# S2-2080 | K070680 | FDA 510(k) | Class II | Active |
| Cardiomems Endosure Pressure Sensor With Delivery System, Model Ads-1001 And Interrogator, Model Ems 5001 | K061046 | FDA 510(k) | Class II | Active |
| Cardiomems Endosure S2 Pressure Sensor With Delivery System, Model S2-2080 | K082191 | FDA 510(k) | Class II | Active |
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