Cobe Renal Care, Inc.
Cobe Renal Care, Inc. appears in FDA public data with 0 recalls, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 25, 1997.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | September 25, 1997 |
| K955592 | COBE CENTRYSYSTEM 14 PES HEMODIALYZERS | April 30, 1997 |
| K955487 | GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS | April 18, 1997 |
| K946279 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | February 10, 1997 |
| K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR | February 6, 1997 |
| K960474 | COBE CENTRYSYSTEM 600 HG HEMODIALYZERS | August 14, 1996 |
| K944436 | COBE CENTRYSYSTEM CS 200 DIALYZER | January 29, 1996 |
| K951311 | GAMBRO HC 14R HEMOCONCENTRATOR | January 11, 1996 |
| K952342 | GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS | September 15, 1995 |
| K945746 | GAMBRO LUNDIA 94-500 DIALYZER | September 8, 1995 |
| K945747 | GAMBRO LUNDIA 94-600 DIALYZER | September 8, 1995 |
| K933883 | GAMBRO FH 66 D HEMOFILTER | March 13, 1995 |
| K933681 | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS | September 7, 1994 |
| K933680 | GAMBRO LUNDIA PRO 200 DIALYZER | August 26, 1994 |