K842416 is an FDA 510(k) clearance for the DUO FLOW CATHETER-MC 54. This device is classified as a Accessories, A-v Shunt (Class II - Special Controls, product code KNZ).
Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1984, 36 days after receiving the submission on June 20, 1984.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K842416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 1984 |
| Decision Date | July 26, 1984 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNZ — Accessories, A-v Shunt |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |