Data / Medical devices / Cardiovascular Delivery Catheter System Positioning And Stabilization Device
Cardiovascular Delivery Catheter System Positioning And Stabilization Device (QWA): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Cardiovascular Delivery Catheter System Positioning And Stabilization Device (product code QWA, Class 1, 21 CFR 870.3955). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QWA
- Device class
- 1
- Regulation
- 870.3955
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Ireland | 2 |
| India | 1 |
| Germany | 1 |
| Canada | 1 |
Makers of Cardiovascular Delivery Catheter System Positioning And Stabilization Device
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Saint Paul, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | Menlo Park, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ebr Systems Inc. | Sunnyvale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ebr Systems Inc. | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Ireland Limited | Limerick Munster, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences LLC | Draper, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences LTD | Shannon Clare, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GCX Corporation | El Paso, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heinrich Medizintechnik GMBH | Stuttgart Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KARDIUM Inc. | Burnaby British Columbia, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.