K010264 is an FDA 510(k) clearance for the NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET, a Protector, Transducer, Dialysis (Class II — Special Controls, product code FIB), submitted by Nipro Medical Corp. (Weston, US). The FDA issued a Cleared decision on April 27, 2001, 88 days after receiving the submission on January 29, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K010264 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 29, 2001 |
| Decision Date | April 27, 2001 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIB — Protector, Transducer, Dialysis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |