FDA Product Code
FDA Product Code FKR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140571 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2014-05-15 | Special | PDF ↗ |
| K111174 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2011-09-19 | Special | PDF ↗ |
| K080919 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2008-10-15 | Traditional | PDF ↗ |
| K060296 | NXSTAGE DIALYSATE PREPARATION MODULE | Nxstage Medical, Inc. | 2006-03-31 | Special | PDF ↗ |
| K043436 | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | Nxstage Medical, Inc. | 2005-03-17 | Traditional | PDF ↗ |
| K850435 | SARTORIUS AQUASART SM 40035 - DIALYSATE SYS | Sartorius Filters, Inc. | 1985-06-04 | Traditional | PDF ↗ |
| K850756 | AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS | Travenol Laboratories, S.A. | 1985-03-20 | Traditional | PDF ↗ |
| K810605 | CHEMATIC BICARBONATE DIALYSATE SYSTEM | Trimedyne, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K810127 | GAMBRO BICARBONATE MODULE, BCM-10 | Gambro, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K802465 | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. | Renal Systems, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K800772 | MOD. DM-357 BICARBONATE RETROFIT KIT | Extracorporeal Medical Specialities, Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K781303 | BIO-PRO UNIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-02 | Traditional | PDF ↗ |
Product code FKR · Class II · Gastroenterology, Urology. Data: openFDA.