Data / Medical devices / Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass / United States
FDA-registered makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass in the United States: 36 establishments
36 establishments in the United States are registered with the FDA to make Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL). 22 have a 510(k) clearance or PMA approval on file and 10 have a recall event. FDA data exported November 2, 2026.
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- Device
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- Product code
- DTL
- Country
- United States
Makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Manufacturer, Specification developer | 6 | August 15, 1990 | 0 | 1 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 4 | December 17, 1996 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer | 4 | June 26, 1990 | 0 | 0 | 0 | api.fda.gov |
| Novosci Corp. | Conroe, TX, United States | Manufacturer, Repackager or relabeler, Specification developer | 4 | June 30, 1980 | 0 | 1 | 0 | api.fda.gov |
| Terumo Cardiovascular Systems Corporation | Elkton, MD, United States | Manufacturer | 3 | March 5, 2008 | 0 | 1 | 0 | api.fda.gov |
| Abbott Vascular | Temecula, CA, United States | Complaint file establishment, Specification developer | 2 | June 9, 1999 | 0 | 2 | 0 | api.fda.gov |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 2 | June 9, 1999 | 0 | 0 | 0 | api.fda.gov |
| Advance Medical Designs, Inc. | Marietta, GA, United States | Manufacturer, Repackager or relabeler | 2 | July 5, 1994 | 0 | 0 | 0 | api.fda.gov |
| Allwell Medical Corporation | Raleigh, NC, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | January 22, 1993 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | October 18, 1984 | 0 | 0 | 0 | api.fda.gov |
| Enablecv, LLC | Midvale, UT, United States | Specification developer | 2 | January 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | June 21, 1995 | 0 | 0 | 0 | api.fda.gov |
| Centurion Medical Products, LP | Williamston, MI, United States | Specification developer | 1 | January 23, 1979 | 0 | 0 | 0 | api.fda.gov |
| Galt Medical Corp. | Garland, TX, United States | Contract manufacturer, Manufacturer | 1 | December 2, 2015 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | September 11, 1991 | 0 | 0 | 0 | api.fda.gov |
| LivaNova USA, INC. | Arvada, CO, United States | Manufacturer | 1 | December 16, 1983 | 0 | 3 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | April 3, 2012 | 0 | 4 | 2 | api.fda.gov |
| Medtronic Vascular | Danvers, MA, United States | Specification developer | 1 | February 3, 1995 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Specification developer | 1 | January 11, 2006 | 0 | 1 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer, Repackager or relabeler | 1 | April 28, 2010 | 0 | 3 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | July 17, 1986 | 0 | 0 | 0 | api.fda.gov |
| Vascular Solutions LLC | Maple Grove, MN, United States | Specification developer | 1 | September 7, 2012 | 0 | 3 | 2 | api.fda.gov |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Curatia Medical Co. | Sunnyvale, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donatelle Plastics, LLC | New Brighton, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeRoyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Excel Medical Products, Inc. | Wixom, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insightra Medical, Inc. | Clarksville, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Grand Rapids | Grand Rapids, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Needle Specialty Products | Boyle, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexus Medical, LLC | Lenexa, KS, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nventric, Inc. | Arcadia, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Neurovascular | Fremont, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trelleborg Sealing Solutions US, Inc | Delano, MN, United States | Contract 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.