K071145 is an FDA 510(k) clearance for the NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE. This device is classified as a Catheter, Hemodialysis, Non-implanted (Class II - Special Controls, product code MPB).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on September 7, 2007, 136 days after receiving the submission on April 24, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K071145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2007 |
| Decision Date | September 07, 2007 |
| Days to Decision | 136 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MPB — Catheter, Hemodialysis, Non-implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |