Data / Medical devices / United States / Total Vein Systems
Total Vein Systems: FDA-registered device maker in Houston, TX, United States, 3 510(k) clearances
Total Vein Systems is registered with the FDA (registration 3005987567) in Houston, TX, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005987567
- Address
- 901 Yale Street, Houston, TX, United States, 77008
- Owner or operator
- Total Vein Systems (10027276)
- Roles
- Repackager or relabeler
- First device listed
- November 23, 2011
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 19, 2025 | K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) | GEX | Substantially Equivalent | Gigaalaser Company , Ltd. | accessdata.fda.gov |
| April 7, 2017 | K160549 | MEDICAL DIODE LASER SYSTEMS | GEX | Substantially Equivalent | Wuhan Gigaa Optronics Technology Co., Ltd. | accessdata.fda.gov |
| November 5, 2013 | K131661 | INFUSION SYRINGE SET | FMF | Substantially Equivalent | Innovative Medical Manufacturing Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Hook, Surgical, General & Plastic Surgery
- All makers of Stocking, Medical Support (For General Medical Purposes)
- All makers of Catheter, Irrigation
- All makers of Forceps
- All makers of Syringe, Piston
Updated March 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.