Data / Medical devices / Ireland / Vantive Manufacturing Limited
Vantive Manufacturing Limited: FDA-registered device maker in CASTLEBAR, COUNTY MAYO Connaught, Ireland, 1 510(k) clearance
Vantive Manufacturing Limited is registered with the FDA (registration 9610725) in CASTLEBAR, COUNTY MAYO Connaught, Ireland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 4, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610725
- FEI number
- 405
- Address
- Moneen RD., CASTLEBAR, COUNTY MAYO Connaught, Ireland, F23 XR63
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 18, 2008
- Registered through
- 2026
- Brand names listed
- Adept, PRISMASATE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Absorbable, Adhesion | MCN | 3 | Contract manufacturer | accessdata.fda.gov |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 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 |
|---|---|---|---|---|---|---|
| February 4, 2008 | K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY | KPO | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
Compare with other makers
- All makers of Barrier, Absorbable, Adhesion
- All makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Updated February 4, 2008. 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.