FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pleurx Pleural Catheter System
K Number: K160450
·
Decision Oct 31, 2016
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
18
Applicant Total
34
Review Days
256
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Basic Information
- Device Name
- Pleurx Pleural Catheter System
- K Number
- K160450
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5050
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Care Fusion
- Date Received
- February 18, 2016
- Decision Date
- October 31, 2016
- 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.
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Passio Pump Drainage System
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Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
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PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
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