Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set— 510(k) K161418
Substantially EquivalentCardinalhealth
FDA 510(k) clearance K161418 for Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set, Substantially Equivalent on 2017-01-19. Applicant: Cardinalhealth. Device class: 2.
Clearance details
- Applicant
- Cardinalhealth
- Product code
- Code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukegan, IL, US
Recent devices under product code OMP
view allMore clearances from Cardinalhealth
view all- K261749 — Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff
- K243660 — Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777) +8 more
- K243652 — Monoject Enteral Syringe with ENFit Connector (6 models)
- K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ) +1 more
Adverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.