The following data is part of a premarket notification filed by Cardiomems, Inc. with the FDA for Cardiomems Endosure S2 14f Wireless Aaa Pressure Measurement System, Model# S2-2080.
| Device ID | K070680 |
| 510k Number | K070680 |
| Device Name: | CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 |
| Classification | Sensor, Pressure, Aneurysm, Implantable |
| Applicant | CARDIOMEMS, INC. 75 FIFTH ST., NW SUITE 440 Atlanta, GA 30308 |
| Contact | Grace Powers |
| Correspondent | Grace Powers CARDIOMEMS, INC. 75 FIFTH ST., NW SUITE 440 Atlanta, GA 30308 |
| Product Code | NQH |
| CFR Regulation Number | 870.2855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-12 |
| Decision Date | 2007-04-05 |
| Summary: | summary |