K771206 is an FDA 510(k) clearance for the AV FISTULA NEEDLE SET. 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 July 15, 1977, 10 days after receiving the submission on July 5, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K771206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1977 |
| Decision Date | July 15, 1977 |
| Days to Decision | 10 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 |