K900125 is an FDA 510(k) clearance for the ARTERIOVENOUS FISTULA SETS. This device is classified as a Needle, Fistula (Class II - Special Controls, product code FIE).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on January 31, 1990, 22 days after receiving the submission on January 9, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K900125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1990 |
| Decision Date | January 31, 1990 |
| Days to Decision | 22 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 |