CROSSLEAD Standard 035 and CROSSLEAD Stiff 035— 510(k) K261281
Substantially EquivalentFilmecc Co., Ltd.
FDA 510(k) clearance K261281 for CROSSLEAD Standard 035 and CROSSLEAD Stiff 035, Substantially Equivalent on 2026-09-03. Applicant: Filmecc Co., Ltd.. Device class: 2.
Summary
Filmecc's clearance covers two guidewires, CROSSLEAD Standard 035 and CROSSLEAD Stiff 035, filed under DQX, catheter guide wires. The record doesn't say what "035" denotes or give other dimensions.
Class II, 21 CFR 870.1330. Cardiovascular is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Filmecc filed from Seto-Shi, Japan. Review took 139 calendar days (April 17 to September 3, 2026).
Clearance details
- Applicant
- Filmecc Co., Ltd.
- Product code
- Product code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seto-Shi, JP
Recent devices under product code DQX
view allMore clearances from Filmecc Co., Ltd.
view allAdverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.