Data / Medical devices / Japan / Filmecc Co., Ltd.
Filmecc Co., Ltd.: FDA-registered device maker in Seto-shi Aichi, Japan, 8 510(k) clearances
Filmecc Co., Ltd. is registered with the FDA (registration 3012223769) in Seto-shi Aichi, Japan. It lists 1 device type. The FDA files 8 510(k) clearances under its listings, the newest dated September 3, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012223769
- FEI number
- 3008411636
- Address
- 3-99 Akatsuki-cho, Seto-shi Aichi, Japan, 4890071
- Owner or operator
- Filmecc Co., Ltd. (10075566)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 17, 2021
- Registered through
- 2026
- Brand names listed
- CROSSLEAD Standard 035, CROSSLEAD Stiff 035, VASSALLO GT 018 Floppy, VASSALLO GT 018 G12, VASSALLO GT 018 G30, VASSALLO GT Crossing, VASSALLO GT Crossing14, VASSALLO GT EXT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 3, 2026 | K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| October 11, 2023 | K232578 | VASSALLO GT 018 G12; VASSALLO GT 018 G30 | DQX | Substantially Equivalent | Filmec Co. , Ltd. | accessdata.fda.gov |
| October 11, 2023 | K232574 | VASSALLO GT Crossing14 | DQX | Substantially Equivalent | Filmec Co. , Ltd. | accessdata.fda.gov |
| March 9, 2023 | K223432 | Vassallo GT 018 Hybrid | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| October 26, 2022 | K222631 | VASSALLO GT EXT | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| June 30, 2022 | K213949 | VASSALLO GT 018 Floppy | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| May 4, 2021 | K203529 | VASSALLO GT Hybrid | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
| April 21, 2021 | K203533 | VASSALLO GT | DQX | Substantially Equivalent | Filmecc Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 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.