K113313 is an FDA 510(k) clearance for the MOLECULAR ADSORBENT RECIRCULATING(MARS). 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 December 14, 2012, 401 days after receiving the submission on November 9, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5870.
| 510(k) Number | K113313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2011 |
| Decision Date | December 14, 2012 |
| Days to Decision | 401 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FLD — Apparatus, Hemoperfusion, Sorbent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5870 |