K893716 is an FDA 510(k) clearance for the VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 18, 1989, 123 days after receiving the submission on May 18, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K893716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1989 |
| Decision Date | September 18, 1989 |
| Days to Decision | 123 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 |