LimFlow Vector— 510(k) K260188
Substantially EquivalentLimFlow, Inc.
FDA 510(k) clearance K260188 for LimFlow Vector, Substantially Equivalent on 2026-03-18. Applicant: LimFlow, Inc.. Device class: 2.
Summary
LimFlow's LimFlow Vector is filed under MGZ, valvulotomes. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 870.4885. Cardiovascular is both the classification panel and the review panel. It was a Special 510(k).
LimFlow filed from Irvine, California. The decision came 55 calendar days after receipt (January 22 to March 18, 2026).
Clearance details
- Applicant
- LimFlow, Inc.
- Product code
- Product code MGZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4885
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
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