FDA Product Code
FDA Product Code NQH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2855
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K082191 | CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 | Cardiomems, Inc. | 2008-08-19 | Abbreviated | PDF ↗ |
| K070680 | CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 | Cardiomems, Inc. | 2007-04-05 | Special | PDF ↗ |
| K070448 | CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 | Cardiomems, Inc. | 2007-03-15 | Abbreviated | PDF ↗ |
| K061046 | CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 | Cardiomems, Inc. | 2006-10-12 | Traditional | PDF ↗ |
| DEN050006 | CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM | Cardiomems, Inc. | 2005-10-28 | Post-NSE | — |
Product code NQH · Class II · Cardiovascular. Data: openFDA.