The following data is part of a premarket notification filed by Cardiomems Inc with the FDA for Cardiomems Endosure S2 Pressure Sensor With Delivery System, Model S2-2080.
| Device ID | K082191 |
| 510k Number | K082191 |
| Device Name: | CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 |
| Classification | Sensor, Pressure, Aneurysm, Implantable |
| Applicant | CARDIOMEMS INC 387 TECHNOLOGY CIRCLE, NW SUITE 500 Atlanta, GA 30313 |
| Contact | Grace Powers |
| Correspondent | Grace Powers CARDIOMEMS INC 387 TECHNOLOGY CIRCLE, NW SUITE 500 Atlanta, GA 30313 |
| Product Code | NQH |
| CFR Regulation Number | 870.2855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-04 |
| Decision Date | 2008-08-19 |
| Summary: | summary |