Cobe Renal Care, Inc.
Lakewood, CO, US
Cobe Renal Care, Inc. appears in FDA device records in Lakewood, CO. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Cobe Renal Care, Inc. between 1994 and 1997. The busiest year on record is 1997, with 5. The most recent is 1997, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 3 |
| 1997 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | KDL | Substantially Equivalent | |
| K955592 | COBE CENTRYSYSTEM 14 PES HEMODIALYZERS | KDI | Substantially Equivalent | |
| K955487 | GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS | KDI | Substantially Equivalent | |
| K946279 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | KDI | Substantially Equivalent | |
| K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR | MQS | Substantially Equivalent | |
| K960474 | COBE CENTRYSYSTEM 600 HG HEMODIALYZERS | KDI | Substantially Equivalent | |
| K944436 | COBE CENTRYSYSTEM CS 200 DIALYZER | FJI | Substantially Equivalent | |
| K951311 | GAMBRO HC 14R HEMOCONCENTRATOR | KDI | Substantially Equivalent | |
| K952342 | GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS | KDI | Substantially Equivalent | |
| K945747 | GAMBRO LUNDIA 94-600 DIALYZER | KDI | Substantially Equivalent | |
| K945746 | GAMBRO LUNDIA 94-500 DIALYZER | FJI | Substantially Equivalent | |
| K933883 | GAMBRO FH 66 D HEMOFILTER | KDI | Substantially Equivalent | |
| K933681 | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS | FJG | Substantially Equivalent | |
| K933680 | GAMBRO LUNDIA PRO 200 DIALYZER | FJG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain