FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PCWP Analysis Software
K Number: DEN250057
·
Decision May 22, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
2
Review Days
186
Basic Information
- Device Name
- PCWP Analysis Software
- K Number
- DEN250057
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 870.1150
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- Cardiosense, Inc.
- Date Received
- November 17, 2025
- Decision Date
- May 22, 2026
- Product Code
- SIF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SIF | Software Device System For Estimation Of Cardiac Pressures | FDA class 2 | Cardiovascular |
Other Clearances by Cardiosense, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243566 | CardioTag | Jul 22, 2025 | Substantially Equivalent |