FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PleuraFlow System
K Number: K150042
·
Decision Jun 2, 2015
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
6
Applicant Total
3
Review Days
144
Basic Information
- Device Name
- PleuraFlow System
- K Number
- K150042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ClearFlow, Inc.
- Date Received
- January 9, 2015
- Decision Date
- June 2, 2015
- Product Code
- OTK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OTK | Wound Drain Catheter System | FDA class 2 | General, Plastic Surgery |
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