REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
FDA 510(k) clearance K954623 · decided 1996-08-28
Clearance details
- K-number
- K954623
- Device name
- REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
- Applicant
- Gambro Healthcare
- Decision
- Substantially Equivalent
- Date received
- 1995-10-05
- Decision date
- 1996-08-28
- Days to decision
- 328 days
- Clearance type
- Traditional
- Product code
- FKT
- Device class
- 2
- Regulation number
- 876.5600
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Oklahoma City, OK, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gambro Healthcare
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 2008 HEMODIALYSIS SORBENT SYSTEM (K123835) | Renal Solutions, Inc. | 2013-02-15 |
| 2008 HEMODIALYSIS SORBENT SYSTEM (K093362) | Renal Solutions, Inc. | 2010-08-13 |
| ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 (K070739) | Renal Solutions, Inc. | 2007-05-25 |
| ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 (K060381) | Renal Solutions, Inc. | 2006-05-24 |
| ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 (K043574) | Renal Solutions, Inc. | 2005-06-03 |
| SORB+HISORB+CARTRIDGE (K031099) | Renal Solutions, Inc. | 2003-09-17 |
| REDY 2000 (K882428) | Organon Teknika Corp. | 1988-10-25 |
| MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR (K874137) | Ash Medical Systems, Inc. | 1988-04-08 |
| MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. (K870270) | Ash Medical Systems, Inc. | 1987-02-25 |
| BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR (K864179) | Ash Medical Systems, Inc. | 1986-12-11 |
| PACKETS FOR PREP. OF DIALYSATES & INFUSATES - (K851188) | Organon Teknika Corp. | 1985-04-12 |
| HEMOPERFUSION PROCEDURE W/REDY 2000 (K842513) | Organon Teknika Corp. | 1984-09-12 |
Recalls involving this device
No recalls on record reference this clearance.