Data / Medical devices / Stylet, Catheter / United States
FDA-registered makers of Stylet, Catheter in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Stylet, Catheter (product code DRB). 11 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Stylet, Catheter
- Product code
- DRB
- Country
- United States
Makers of Stylet, Catheter in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Spectranetics Corp. | Colorado Springs, CO, United States | Complaint file establishment, Manufacturer | 3 | August 12, 2014 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Sylmar, CA, United States | Manufacturer, Specification developer | 2 | April 1, 2009 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | November 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Villalba | Villalba, PR, United States | Manufacturer | 2 | April 5, 2001 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 1 | August 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cook Vandergrift Inc. | Vandergrift, PA, United States | Complaint file establishment, Manufacturer | 1 | October 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 1 | July 28, 1988 | 0 | 0 | 0 | api.fda.gov |
| Galt Medical Corp. | Garland, TX, United States | Manufacturer | 1 | May 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 1 | October 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | April 13, 2000 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | April 13, 2000 | 0 | 0 | 0 | api.fda.gov |
| Acme-Monaco Corp. | New Britain, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acme-Monaco Corp. | Presque Isle, ME, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heraeus Medical Components Caribe, Inc. | Dorado, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, 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.