K133807 is an FDA 510(k) clearance for the MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT. This device is classified as a Apparatus, Hemoperfusion, Sorbent (Class II - Special Controls, product code FLD).
Submitted by Gambro Renal Products, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 26, 2014, 100 days after receiving the submission on December 16, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5870.
| 510(k) Number | K133807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2013 |
| Decision Date | March 26, 2014 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FLD — Apparatus, Hemoperfusion, Sorbent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5870 |