FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Passio Pump Drainage System
K Number: K190292
·
Decision Jul 25, 2019
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
18
Applicant Total
3
Review Days
164
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Basic Information
- Device Name
- Passio Pump Drainage System
- K Number
- K190292
- 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
- February 11, 2019
- Decision Date
- July 25, 2019
- 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 |
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