Data / Medical devices / United States / Venclose, Inc.
Venclose, Inc.: FDA-registered device maker in San Jose, CA, United States, 4 510(k) clearances
Venclose, Inc. is registered with the FDA (registration 3011879048) in San Jose, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated August 19, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011879048
- Address
- 2570 N 1st St Fl 2 # 221, San Jose, CA, United States, 95131
- Owner or operator
- C.R. Bard (10049916)
- Roles
- Manufacturer
- First device listed
- October 10, 2016
- Registered through
- 2027
- Brand names listed
- Venclose EVSRF Catheter, Venclose EVSRF Catheter; Venclose RF Ablation Catheter, Venclose Foot Pedal, Venclose Maven Catheter, Venclose Maven Perforator Catheter, Venclose Maven Perforator RF Catheter, Venclose Maven System, Venclose Power Cord and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 19, 2025 | K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) | GEI | Substantially Equivalent | Venclose, Inc. | accessdata.fda.gov |
| February 4, 2025 | K250068 | Venclose digiRF Generator (VCRFG1) | GEI | Substantially Equivalent | Venclose, Inc. | accessdata.fda.gov |
| August 3, 2021 | K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter | GEI | Substantially Equivalent | Venclose, Inc. | accessdata.fda.gov |
| September 9, 2016 | K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) | GEI | Substantially Equivalent | Venclose, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 19, 2025. 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.