FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
K Number: K141965
·
Decision Jul 2, 2015
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
18
Applicant Total
34
Review Days
346
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Basic Information
- Device Name
- PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT
- K Number
- K141965
- 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
- July 21, 2014
- Decision Date
- July 2, 2015
- 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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