K811685 is an FDA 510(k) clearance for the I.V. ADMINISTRATION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Quest Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1981, 15 days after receiving the submission on June 15, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K811685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1981 |
| Decision Date | June 30, 1981 |
| Days to Decision | 15 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 |