K801966 is an FDA 510(k) clearance for the HEMO-CATH II KIDNEY DIALYSIS CATHETER. This device is classified as a Needle, Fistula (Class II - Special Controls, product code FIE).
Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980, 38 days after receiving the submission on August 19, 1980.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K801966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1980 |
| Decision Date | September 26, 1980 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FIE — Needle, Fistula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |