K001465 is an FDA 510(k) clearance for the NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET. This device is classified as 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 December 5, 2000, 209 days after receiving the submission on May 10, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K001465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2000 |
| Decision Date | December 05, 2000 |
| Days to Decision | 209 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 |