510(k) K954623
- Device
- REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
- Applicant
- GAMBRO HEALTHCARE
- 510(k) number
- K954623
- Product code
- FKT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-08-28
- Date received
- 1995-10-05
- Regulation
- 876.5600
- Classification name
- System, Dialysate Delivery, Sorbent Regenerated
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MATHEW M HULL
- Address
- 3631 SW 54th St. Oklahoma City OK US 73119 73119
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FKT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | 2013-02-15 |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | 2010-08-13 |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | Renal Solutions, Inc. | 2007-05-25 |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | Renal Solutions, Inc. | 2006-05-24 |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | Renal Solutions, Inc. | 2005-06-03 |
| K031099 | SORB+HISORB+CARTRIDGE | Renal Solutions, Inc. | 2003-09-17 |
| K882428 | REDY 2000 | Organon Teknika Corp. | 1988-10-25 |
| K874137 | MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR | Ash Medical Systems, Inc. | 1988-04-08 |
| K870270 | MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. | Ash Medical Systems, Inc. | 1987-02-25 |
| K864179 | BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR | Ash Medical Systems, Inc. | 1986-12-11 |
| K851188 | PACKETS FOR PREP. OF DIALYSATES & INFUSATES - | Organon Teknika Corp. | 1985-04-12 |
| K842513 | HEMOPERFUSION PROCEDURE W/REDY 2000 | Organon Teknika Corp. | 1984-09-12 |
| K813574 | SORB II | Organon Teknika Corp. | 1982-03-23 |
| K812869 | D-3260 SORBENT CARTRIDGE | Organon Teknika Corp. | 1981-12-08 |
| K811170 | D-3160 SORBENT CARTRIDGE | Organon Teknika Corp. | 1981-07-31 |
Legacy Summary#
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FDA Review#
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