510(k) clearance
Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)
- 510(k) number
- K260168
- Applicant
- Skycade Med Corporation
- Decision date
- Oct 16, 2026
- Date received
- Jan 20, 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
- Dallas, TX, US