The following data is part of a premarket notification filed by Cardiomems, Inc. with the FDA for Cardiomems Endosure Pressure Sensor With Delivery System, Model Ads-1001 And Interrogator, Model Ems 5001.
| Device ID | K061046 |
| 510k Number | K061046 |
| Device Name: | CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 |
| Classification | Sensor, Pressure, Aneurysm, Implantable |
| Applicant | CARDIOMEMS, INC. 75 FIFTH ST., NW SUITE 440 Atlanta, GA 30308 |
| Contact | Carol Vierling |
| Correspondent | Carol Vierling CARDIOMEMS, INC. 75 FIFTH ST., NW SUITE 440 Atlanta, GA 30308 |
| Product Code | NQH |
| CFR Regulation Number | 870.2855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-14 |
| Decision Date | 2006-10-12 |
| Summary: | summary |