K810317 is an FDA 510(k) clearance for the NITROGLYCERINE IV SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 27, 1981, 110 days after receiving the submission on February 6, 1981.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K810317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1981 |
| Decision Date | May 27, 1981 |
| Days to Decision | 110 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 |