Data / Medical devices / Catheter, Percutaneous, Cutting/Scoring / United States
FDA-registered makers of Catheter, Percutaneous, Cutting/Scoring in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Catheter, Percutaneous, Cutting/Scoring (product code PNO). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Catheter, Percutaneous, Cutting/Scoring
- Product code
- PNO
- Country
- United States
Makers of Catheter, Percutaneous, Cutting/Scoring in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Specification developer | 2 | September 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| VENTUREMED GROUP, Inc | Plymouth, MN, United States | Complaint file establishment, Specification developer | 2 | September 11, 2020 | 0 | 0 | 0 | api.fda.gov |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Manufacturer | 2 | June 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cagent Vascular | Wayne, PA, United States | Complaint file establishment, Specification developer | 1 | April 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | March 27, 2015 | 0 | 1 | 1 | api.fda.gov |
| Spectranetics Corp. | Fremont, CA, United States | Complaint file establishment, Manufacturer | 1 | April 8, 2015 | 0 | 0 | 0 | api.fda.gov |
| BIOMERICS Advanced Catheter | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meraqi Medical, Inc. | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springboard Manufacturing | Rancho Cordova, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.