Gambro Healthcare
Oklahoma City, OK, US
Gambro Healthcare appears in FDA device records in Oklahoma City, OK. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Gambro Healthcare between 1996 and 2000. The busiest year on record is 1998, with 5. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 5 |
| 1999 | 3 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K994390 | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER | MSF | Substantially Equivalent | |
| K990039 | GAMBRO DQM 200 | LFP | Substantially Equivalent | |
| K982413 | COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS | KDI | Substantially Equivalent | |
| K982414 | GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS | KDI | Substantially Equivalent | |
| K980386 | HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) | KDI | Substantially Equivalent | |
| K982760 | COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET | KDI | Substantially Equivalent | |
| K982818 | HOSPAL TIPSTOP | KMF | Substantially Equivalent | |
| K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H | FIP | Substantially Equivalent | |
| K981681 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | KDI | Substantially Equivalent | |
| K981085 | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM | FIP | Substantially Equivalent | |
| K970253 | COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET | KDI | Substantially Equivalent | |
| K962427 | COBE CENTRYSYSTEM 700 HG HEMODIALYZER | KDI | Substantially Equivalent | |
| K954623 | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) | FKT | 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