Data / Medical devices / Ventricular (Assist) Bypass / United States
FDA-registered makers of Ventricular (Assist) Bypass in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Ventricular (Assist) Bypass (product code DSQ). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Ventricular (Assist) Bypass
- Product code
- DSQ
- Country
- United States
Makers of Ventricular (Assist) Bypass in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Thoratec Corp | Burlington, MA, United States | Complaint file establishment, Specification developer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Thoratec Corp. | Pleasanton, CA, United States | Manufacturer | 0 | 3 | 29 | 9 | api.fda.gov | |
| Thoratec Corporation | San Ramon, CA, United States | Manufacturer | 0 | 3 | 0 | 0 | api.fda.gov | |
| HeartWare, Inc. | Miami Lakes, FL, United States | Manufacturer | 0 | 1 | 35 | 19 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Inventus Power | Woodridge, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lowell,inc. | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polo Custom Products | Monticello, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips-Medisize Costa Mesa LLC | Costa Mesa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Cardiovascular Systems Thi Plant | Ann Arbor, MI, United States | Manufacturer for export | 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.