FLD — Apparatus, Hemoperfusion, Sorbent Class II
FDA Device Classification
Classification Details
- Product Code
- FLD
- Device Class
- Class II
- Regulation Number
- 876.5870
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K133807 | gambro renal products | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONT | March 26, 2014 |
| K113313 | gambro renal products | MOLECULAR ADSORBENT RECIRCULATING(MARS) | December 14, 2012 |
| K033262 | gambro renal products | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) | May 27, 2005 |
| K992196 | hemocleanse | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) | September 10, 1999 |
| K984546 | hemocleanse | BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000- | August 13, 1999 |
| K971015 | american health care systems | AHCS HEMOPERFUSION SYSTEM | October 22, 1997 |
| K953751 | hemocleanse | BIOLOGIC-DT SYSTEM | February 15, 1996 |
| K885017 | asahi medical co | HEMOSORBA CH-500, CH-350 AND CH-180 | March 17, 1989 |
| K873643 | gambro | GAMBRO ADSORBA 150C | December 29, 1987 |
| K840532 | extracorporeal medical specialities | HEMOPERFUSION SYSTEM TP-400 | May 30, 1984 |
| K831029 | extracorporeal medical specialities | HEMOPERFUSION SYSTEM TP-400 | August 26, 1983 |