FDA Product Code
FDA Product Code FKT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5600
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | 2013-02-15 | Special | PDF ↗ |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | 2010-08-13 | Abbreviated | PDF ↗ |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | Renal Solutions, Inc. | 2007-05-25 | Special | PDF ↗ |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | Renal Solutions, Inc. | 2006-05-24 | Special | PDF ↗ |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | Renal Solutions, Inc. | 2005-06-03 | Traditional | PDF ↗ |
| K031099 | SORB+HISORB+CARTRIDGE | Renal Solutions, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K954623 | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) | Gambro Healthcare | 1996-08-28 | Traditional | PDF ↗ |
| K882428 | REDY 2000 | Organon Teknika Corp. | 1988-10-25 | Traditional | PDF ↗ |
| K874137 | MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR | Ash Medical Systems, Inc. | 1988-04-08 | Traditional | PDF ↗ |
| K870270 | MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. | Ash Medical Systems, Inc. | 1987-02-25 | Traditional | PDF ↗ |
| K864179 | BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR | Ash Medical Systems, Inc. | 1986-12-11 | Traditional | PDF ↗ |
| K851188 | PACKETS FOR PREP. OF DIALYSATES & INFUSATES - | Organon Teknika Corp. | 1985-04-12 | Traditional | PDF ↗ |
| K842513 | HEMOPERFUSION PROCEDURE W/REDY 2000 | Organon Teknika Corp. | 1984-09-12 | Traditional | PDF ↗ |
| K813574 | SORB II | Organon Teknika Corp. | 1982-03-23 | Traditional | PDF ↗ |
| K812869 | D-3260 SORBENT CARTRIDGE | Organon Teknika Corp. | 1981-12-08 | Traditional | PDF ↗ |
| K811170 | D-3160 SORBENT CARTRIDGE | Organon Teknika Corp. | 1981-07-31 | Traditional | PDF ↗ |
| K801440 | SORB 10 DIALYSATE INFUSATE C1 INFUSATE | Organon Teknika Corp. | 1980-07-21 | Traditional | PDF ↗ |
| K801385 | K1 POTASSIUM ACETATE ADDITIVE | Organon Teknika Corp. | 1980-07-21 | Traditional | PDF ↗ |
| K792137 | SORB SYSTEM URS | Organon Teknika Corp. | 1980-01-16 | Traditional | PDF ↗ |
Product code FKT · Class II · Gastroenterology, Urology. Data: openFDA.