510(k) clearance
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
- 510(k) number
- K261281
- Applicant
- Filmecc Co., Ltd.
- Decision date
- Sep 3, 2026
- Date received
- Apr 17, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DQX
- Device type
- Wire, Guide, Catheter
- Device class
- Class II
- Regulation
- 21 CFR 870.1330
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Seto-Shi, JP