K870188 is an FDA 510(k) clearance for the NORFOLK MEDICAL BUTTERFLY INFUSION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on February 10, 1987, 25 days after receiving the submission on January 16, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K870188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1987 |
| Decision Date | February 10, 1987 |
| Days to Decision | 25 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 |