Central Venous Pressure System
FDA 510(k) clearance K151776 · decided 2015-08-12
Clearance details
- K-number
- K151776
- Device name
- Central Venous Pressure System
- Applicant
- Mespere Lifesciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-01
- Decision date
- 2015-08-12
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- PFA
- Device class
- 2
- Regulation number
- 870.1140
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waterloo, CA
- 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 |
|---|---|---|
| CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 (K131085) | Mespere Lifesciences, Inc. | 2013-08-22 |
Recalls involving this device
No recalls on record reference this clearance.