Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home— 510(k) K143016
Substantially EquivalentCardinalhealth
FDA 510(k) clearance K143016 for Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home, Substantially Equivalent on 2015-04-20. 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 →
Recalls naming K143016
K-number listed on FDA's recall record- Z-2543-2020 — Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
- Z-2544-2020 — Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143016.
Data sourced from openFDA. This site is unofficial and independent of the FDA.