K772362 is an FDA 510(k) clearance for the AVF SET FOR SINGLE NEEDLE HEMODIALYSIS. This device is classified as a Needle, Fistula (Class II — Special Controls, product code FIE).
Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1978, 80 days after receiving the submission on December 27, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K772362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1977 |
| Decision Date | March 17, 1978 |
| Days to Decision | 80 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 |