PCWP Analysis Software
FDA 510(k) clearance DEN250057 · decided 2026-05-22
Clearance details
- K-number
- DEN250057
- Device name
- PCWP Analysis Software
- Applicant
- Cardiosense, Inc.
- Decision
- Unknown
- Date received
- 2025-11-17
- Decision date
- 2026-05-22
- Days to decision
- 186 days
- Clearance type
- Direct
- Product code
- SIF
- Device class
- 2
- Regulation number
- 870.1150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cardiosense
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.
Recalls involving this device
No recalls on record reference this clearance.