Data / Medical devices / Mexico / Cardiva Medical, Inc.
Cardiva Medical, Inc.: FDA-registered device maker in Guaymas Sonora, Mexico, 1 PMA approval
Cardiva Medical, Inc. is registered with the FDA (registration 3011469355) in Guaymas Sonora, Mexico. It lists 3 device types. The FDA files 1 PMA approval under its listings, the newest dated January 31, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011469355
- Address
- Carretera Internacional Km. 129, Salida Norte de Guaymas Parque Industrial Rocafuerte, Guaymas Sonora, Mexico, 85340
- Owner or operator
- CARDIVA MEDICAL, INC. (9058841)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 15, 2013
- Registered through
- 2026
- Brand names listed
- OptoWire III, VASCADE 5F VCS, VASCADE 6/7F VCS, VASCADE MVP VVCS 6-12F, VASCADE MVP XL VVCS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Hemostasis, Vascular | MGB | 3 | Manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Contract manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Contract manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 31, 2013 | P120016 | VASCADE VASCULAR CLOSURE SYSTEM | MGB | 40 | September 10, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Pressure, Catheter Tip
- All makers of Wire, Guide, Catheter
- All makers of Device, Hemostasis, Vascular
Updated September 10, 2026. 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.