The following data is part of a premarket notification filed by Cardiomems Inc with the FDA for Cardiomems Endosure Wireless Aaa Pressure Measurement System, Model Ads-1001.
| Device ID | K070448 |
| 510k Number | K070448 |
| Device Name: | CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-15 |
| Decision Date | 2007-03-15 |
| Summary: | summary |