K861390 is an FDA 510(k) clearance for the DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Baxter Healthcare Corp (Hooksett, US). The FDA issued a Cleared decision on July 17, 1986, 94 days after receiving the submission on April 14, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K861390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1986 |
| Decision Date | July 17, 1986 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |