FLD — Apparatus, Hemoperfusion, Sorbent Class II
FDA product code FLD covers "Apparatus, Hemoperfusion, Sorbent", a Class II medical device regulated under 21 CFR 876.5870. Submissions are reviewed by the Gastroenterology, Urology panel. At least 11 recent 510(k) clearances have been granted under this product code.
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 |