K201207 is an FDA 510(k) clearance for the CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line. This device is classified as a Accessories, Blood Circuit, Hemodialysis (Class II - Special Controls, product code KOC).
Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on September 18, 2020, 136 days after receiving the submission on May 5, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K201207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2020 |
| Decision Date | September 18, 2020 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOC — Accessories, Blood Circuit, Hemodialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |