FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Passio Pump Drainage System
K Number: K201404
·
Decision Nov 20, 2020
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
18
Applicant Total
3
Review Days
176
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Passio Pump Drainage System
- K Number
- K201404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5050
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bearpac Medical
- Date Received
- May 28, 2020
- Decision Date
- November 20, 2020
- Product Code
- DWM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DWM | Apparatus, Suction, Patient Care | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWM), ordered by most recent decision date.
Aspira Pleural Drainage System
FDA 510(k)
FDA Class 2
·Cardiovascular
Rocket Platinum Cured Cathter
FDA 510(k)
FDA Class 2
·Cardiovascular
Passio Pump Drainage System
FDA 510(k)
FDA Class 2
·Cardiovascular
Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
Pleurx Pleural Catheter System
FDA 510(k)
FDA Class 2
·Cardiovascular
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
FDA 510(k)
FDA Class 2
·Cardiovascular