Data / Medical devices / Mexico / Gambro Renal Products S.A. De C.V.
Gambro Renal Products S.A. De C.V.: FDA-registered device maker in TIJUANA Baja California, Mexico, 3 510(k) clearances
Gambro Renal Products S.A. De C.V. is registered with the FDA (registration 8030638) in TIJUANA Baja California, Mexico. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 30, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8030638
- FEI number
- 3002806727
- Address
- BLVD Pacifico 10014 Parque Industrial Pacifico, TIJUANA Baja California, Mexico, CP 22643
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Manufacturer
- First device listed
- May 18, 2008
- Registered through
- 2026
- Brand names listed
- Artiset, Automated PD Set with Cassette 4-Prong, CARTRIDGE BLOOD SET, GAMBRO CARTRIDGE BLOOD SETS, HomeChoice PRO Automated Personal Cycler, Homechoice, Integrated APD Set with Cassette 3-prong, Low Recirculation Volume APD Set with Cassette and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Manufacturer | accessdata.fda.gov |
| System, Peritoneal, Automatic Delivery | FKX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 30, 2011 | K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R | FKX | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| November 3, 2010 | K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | FJK | Substantially Equivalent | Gambro Renal Products, Inc. | accessdata.fda.gov |
| October 12, 2007 | K070414 | GAMBRO CARTRIDGE BLOOD SETS | FJK | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- All makers of System, Peritoneal, Automatic Delivery
Updated March 30, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.