FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
K Number: K161418
·
Decision Jan 19, 2017
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
204
Applicant Total
5
Review Days
241
Basic Information
- Device Name
- Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
- K Number
- K161418
- 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
- CARDINAL HEALTH
- Date Received
- May 23, 2016
- Decision Date
- January 19, 2017
- Product Code
- OMP
- 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 |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | FDA class 2 | General, Plastic Surgery |
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Other Clearances by CARDINAL HEALTH
| K Number | Device Name | ||
|---|---|---|---|
| K150124 | Cardinal Health NPWT PRO HC | Sep 2, 2015 | Substantially Equivalent |
| K150579 | Cardinal Health External Fixation System | Apr 29, 2015 | Substantially Equivalent |
| K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home | Apr 20, 2015 | Substantially Equivalent |
| K142916 | SVED Wound Treatment System | Mar 4, 2015 | Substantially Equivalent |