CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
FDA 510(k) clearance K131085 · decided 2013-08-22
Clearance details
- K-number
- K131085
- Device name
- CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
- Applicant
- Mespere Lifesciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-18
- Decision date
- 2013-08-22
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- PFA
- Device class
- 2
- Regulation number
- 870.1140
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waterloo, On, CA
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mespere Lifesciences
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (K151776) | Mespere Lifesciences, Inc. | 2015-08-12 |
Recalls involving this device
No recalls on record reference this clearance.