Company ยท US
Cobe Renal Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1997. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 1997 | K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET Cobe Renal Care, Inc. | KDL |
| Apr 30, 1997 | K955592 | COBE CENTRYSYSTEM 14 PES HEMODIALYZERS Cobe Renal Care, Inc. | KDI |
| Apr 18, 1997 | K955487 | GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS Cobe Renal Care, Inc. | KDI |
| Feb 10, 1997 | K946279 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) Cobe Renal Care, Inc. | KDI |
| Feb 6, 1997 | K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR Cobe Renal Care, Inc. | MQS |
| Aug 14, 1996 | K960474 | COBE CENTRYSYSTEM 600 HG HEMODIALYZERS Cobe Renal Care, Inc. | KDI |
| Jan 29, 1996 | K944436 | COBE CENTRYSYSTEM CS 200 DIALYZER Cobe Renal Care, Inc. | FJI |
| Jan 11, 1996 | K951311 | GAMBRO HC 14R HEMOCONCENTRATOR Cobe Renal Care, Inc. | KDI |
| Sep 15, 1995 | K952342 | GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS Cobe Renal Care, Inc. | KDI |
| Sep 8, 1995 | K945747 | GAMBRO LUNDIA 94-600 DIALYZER Cobe Renal Care, Inc. | KDI |
| Sep 8, 1995 | K945746 | GAMBRO LUNDIA 94-500 DIALYZER Cobe Renal Care, Inc. | FJI |
| Mar 13, 1995 | K933883 | GAMBRO FH 66 D HEMOFILTER Cobe Renal Care, Inc. | KDI |
| Sep 7, 1994 | K933681 | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS Cobe Renal Care, Inc. | FJG |
| Aug 26, 1994 | K933680 | GAMBRO LUNDIA PRO 200 DIALYZER Cobe Renal Care, Inc. | FJG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||