K883718 is an FDA 510(k) clearance for the MERIT HI-FLEX(TM). This device is classified as a Tubing, Fluid Delivery (Class II - Special Controls, product code FPK).
Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 30, 1989, 152 days after receiving the submission on August 31, 1988.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K883718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 1988 |
| Decision Date | January 30, 1989 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPK — Tubing, Fluid Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |