K792141 is an FDA 510(k) clearance for the CONTINUOUS FLUSH DEVICE. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 5, 1979, 44 days after receiving the submission on October 22, 1979.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K792141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1979 |
| Decision Date | December 05, 1979 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |