K945850 is an FDA 510(k) clearance for the BRAUN DIACAN(R) FISTULA NEEDLES. This device is classified as a Needle, Fistula (Class II - Special Controls, product code FIE).
Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 6, 1995, 310 days after receiving the submission on November 30, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K945850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1994 |
| Decision Date | October 06, 1995 |
| Days to Decision | 310 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIE — Needle, Fistula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |