Data / Medical devices / Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF): 59 FDA-registered makers in 10 countries

59 establishments in 10 countries are registered with the FDA to make Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF, Class 2, 21 CFR 870.4210). 32 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 403 510(k) clearances under this code, the latest on October 1, 2026, and lists 98 recall events (7 Class I). FDA data exported November 3, 2026.

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Product code

DWF

Device class

2

Regulation

870.4210

Medical specialty

Cardiovascular

Makers by country

Makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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.

Updated October 1, 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.