Data / Medical devices / United States / Cagent Vascular
Cagent Vascular: FDA-registered device maker in Wayne, PA, United States, 1 510(k) clearance
Cagent Vascular is registered with the FDA (registration 3014598164) in Wayne, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 15, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014598164
- Address
- 150 Strafford Avenue #315, Wayne, PA, United States, 19087
- Owner or operator
- Cagent Vascular (10060763)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 15, 2020
- Registered through
- 2026
- Brand names listed
- Serranator PTA Serration Balloon Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous, Cutting/Scoring | PNO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2020 | K193181 | Serranator PTA Serration Balloon Catheter | PNO | Substantially Equivalent | Cagent Vascular, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 15, 2020. 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.