Data / Medical devices / Singapore / Vantive Manufacturing Pte. Ltd.
Vantive Manufacturing Pte. Ltd.: FDA-registered device maker in SINGAPORE Central Singapore, Singapore, 2 510(k) clearances
Vantive Manufacturing Pte. Ltd. is registered with the FDA (registration 9612057) in SINGAPORE Central Singapore, Singapore. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612057
- FEI number
- 3002806460
- Address
- 2 WOODLANDS INDUSTRIAL PARK D Street 2, SINGAPORE Central Singapore, Singapore, 737778
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- April 1, 2020
- Registered through
- 2026
- Brand names listed
- Automated PD Set with Cassette 4-Prong, HomeChoice PRO Automated Personal Cycler, Homechoice, Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System, Integrated APD Set with Cassette 3-prong, Low Recirculation Volume APD Set with Cassette, Needle, Hypodermic, Single Lumen, Solution Sets w/Capless Luer Valve
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract sterilizer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| November 19, 2020 | K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System | FKX | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| 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 |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of System, Peritoneal, Automatic Delivery
- All makers of Syringe, Piston
- All makers of Set, Administration, Intravascular
Updated November 19, 2020. 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.