The following data is part of a premarket notification filed by Cardinal Health with the FDA for Cardinal Health Npwt Irrigation Tubing Set, Cardinal Health Npwt Irrigation Delivery Set.
| Device ID | K161418 |
| 510k Number | K161418 |
| Device Name: | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | CARDINAL HEALTH 1500 S Waukegan Rd Waukegan, IL 60085 |
| Contact | Judith Harbour |
| Correspondent | Tatyana Bogdan-curvin CARDINAL HEALTH 1500 S Waukegan Rd Waukegan, IL 60085 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2017-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50192253011430 | K161418 | 000 |
| 50192253011423 | K161418 | 000 |