K112628 is an FDA 510(k) clearance for the NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET. This device is classified as a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II - Special Controls, product code FJK).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on September 28, 2012, 385 days after receiving the submission on September 9, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K112628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2011 |
| Decision Date | September 28, 2012 |
| Days to Decision | 385 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |