MOLECULAR ADSORBENT RECIRCULATING(MARS)
FDA 510(k) clearance K113313 · decided 2012-12-14
Clearance details
- K-number
- K113313
- Device name
- MOLECULAR ADSORBENT RECIRCULATING(MARS)
- Applicant
- Gambro Renal Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-09
- Decision date
- 2012-12-14
- Days to decision
- 401 days
- Clearance type
- Traditional
- Product code
- FLD
- Device class
- 2
- Regulation number
- 876.5870
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT (K133807) | Gambro Renal Products, Inc. | 2014-03-26 |
| MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) (K033262) | Gambro Renal Products | 2005-05-27 |
| BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) (K992196) | Hemocleanse, Inc. | 1999-09-10 |
| BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK (K984546) | Hemocleanse, Inc. | 1999-08-13 |
| AHCS HEMOPERFUSION SYSTEM (K971015) | American Health Care Systems, Inc. | 1997-10-22 |
| BIOLOGIC-DT SYSTEM (K953751) | Hemocleanse, Inc. | 1996-02-15 |
| HEMOSORBA CH-500, CH-350 AND CH-180 (K885017) | Asahi Medical Co., Ltd. | 1989-03-17 |
| GAMBRO ADSORBA 150C (K873643) | Gambro, Inc. | 1987-12-29 |
| HEMOPERFUSION SYSTEM TP-400 (K840532) | Extracorporeal Medical Specialities, Inc. | 1984-05-30 |
| HEMOPERFUSION SYSTEM TP-400 (K831029) | Extracorporeal Medical Specialities, Inc. | 1983-08-26 |
Recalls involving this device
No recalls on record reference this clearance.