K862653 is an FDA 510(k) clearance for the LUER LOCK ADAPTER/NUT. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Mallinckrodt Critical Care (St Louis, US). The FDA issued a Cleared decision on July 31, 1986, 17 days after receiving the submission on July 14, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K862653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1986 |
| Decision Date | July 31, 1986 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |