CHEMATIC BICARBONATE DIALYSATE SYSTEM
FDA 510(k) clearance K810605 · decided 1981-06-16
Clearance details
- K-number
- K810605
- Device name
- CHEMATIC BICARBONATE DIALYSATE SYSTEM
- Applicant
- Trimedyne, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-06
- Decision date
- 1981-06-16
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- FKR
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NXSTAGE PUREFLOW SL (K140571) | Nxstage Medical, Inc. | 2014-05-15 |
| NXSTAGE PUREFLOW SL (K111174) | Nxstage Medical, Inc. | 2011-09-19 |
| NXSTAGE PUREFLOW SL (K080919) | Nxstage Medical, Inc. | 2008-10-15 |
| NXSTAGE DIALYSATE PREPARATION MODULE (K060296) | Nxstage Medical, Inc. | 2006-03-31 |
| NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (K043436) | Nxstage Medical, Inc. | 2005-03-17 |
| SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (K850435) | Sartorius Filters, Inc. | 1985-06-04 |
| AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS (K850756) | Travenol Laboratories, S.A. | 1985-03-20 |
| GAMBRO BICARBONATE MODULE, BCM-10 (K810127) | Gambro, Inc. | 1981-02-25 |
| BICARB-O-MATE HEMODIALYSIS SOD. BICARB. (K802465) | Renal Systems, Inc. | 1980-11-12 |
| MOD. DM-357 BICARBONATE RETROFIT KIT (K800772) | Extracorporeal Medical Specialities, Inc. | 1980-05-14 |
| BIO-PRO UNIT (K781303) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S026) | Trimedyne, Inc. | 1994-03-17 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S016) | Trimedyne, Inc. | 1994-03-17 |
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S027) | Trimedyne, Inc. | 1994-03-01 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S015) | Trimedyne, Inc. | 1992-03-20 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S014) | Trimedyne, Inc. | 1992-01-29 |
| MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM (P870043/S013) | Trimedyne, Inc. | 1991-08-20 |
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S025) | Trimedyne, Inc. | 1991-02-25 |
| 2.5 HOLIUM/ND:YAG SPECTRAPROBE FLEX CATHETER (P870043/S011) | Trimedyne, Inc. | 1990-11-14 |