K033262 is an FDA 510(k) clearance for the MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS). This device is classified as a Apparatus, Hemoperfusion, Sorbent (Class II - Special Controls, product code FLD).
Submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on May 27, 2005, 596 days after receiving the submission on October 9, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5870.
| 510(k) Number | K033262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2003 |
| Decision Date | May 27, 2005 |
| Days to Decision | 596 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 |