FDA Product Code
FDA Product Code FLD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5870
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT | Gambro Renal Products, Inc. | 2014-03-26 | Traditional | PDF ↗ |
| K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) | Gambro Renal Products, Inc. | 2012-12-14 | Traditional | PDF ↗ |
| K033262 | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) | Gambro Renal Products | 2005-05-27 | Traditional | PDF ↗ |
| K992196 | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) | Hemocleanse, Inc. | 1999-09-10 | Special | PDF ↗ |
| K984546 | BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK | Hemocleanse, Inc. | 1999-08-13 | Traditional | PDF ↗ |
| K971015 | AHCS HEMOPERFUSION SYSTEM | American Health Care Systems, Inc. | 1997-10-22 | Traditional | PDF ↗ |
| K953751 | BIOLOGIC-DT SYSTEM | Hemocleanse, Inc. | 1996-02-15 | Traditional | PDF ↗ |
| K885017 | HEMOSORBA CH-500, CH-350 AND CH-180 | Asahi Medical Co., Ltd. | 1989-03-17 | Traditional | PDF ↗ |
| K873643 | GAMBRO ADSORBA 150C | Gambro, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K840532 | HEMOPERFUSION SYSTEM TP-400 | Extracorporeal Medical Specialities, Inc. | 1984-05-30 | Traditional | PDF ↗ |
| K831029 | HEMOPERFUSION SYSTEM TP-400 | Extracorporeal Medical Specialities, Inc. | 1983-08-26 | Traditional | PDF ↗ |
Product code FLD · Class II · Gastroenterology, Urology. Data: openFDA.