510(k) K061046
- Device
- CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001
- Applicant
- CARDIOMEMS, INC.
- 510(k) number
- K061046
- Product code
- NQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-12
- Date received
- 2006-04-14
- Regulation
- 870.2855
- Classification name
- Sensor, Pressure, Aneurysm, Implantable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL VIERLING
- Address
- 75 Fifth St., NW Suite 440 Atlanta GA US 30308 30308
Source Documents#
Other 510(k) Records For Product Code NQH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K082191 | CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 | Cardiomems, Inc. | 2008-08-19 |
| K070680 | CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 | Cardiomems, Inc. | 2007-04-05 |
| K070448 | CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 | Cardiomems, Inc. | 2007-03-15 |
| DEN050006 | CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM | Cardiomems, Inc. | 2005-10-28 |
Legacy Summary#
summary
FDA Review#
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