CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
FDA 510(k) clearance K082191 · decided 2008-08-19
Clearance details
- K-number
- K082191
- Device name
- CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
- Applicant
- Cardiomems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-04
- Decision date
- 2008-08-19
- Days to decision
- 15 days
- Clearance type
- Abbreviated
- Product code
- NQH
- Device class
- 2
- Regulation number
- 870.2855
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 (K070680) | Cardiomems, Inc. | 2007-04-05 |
| CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 (K070448) | Cardiomems, Inc. | 2007-03-15 |
| CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 (K061046) | Cardiomems, Inc. | 2006-10-12 |
| CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM (DEN050006) | Cardiomems, Inc. | 2005-10-28 |
Recalls involving this device
No recalls on record reference this clearance.