LimFlow Vector

FDA 510(k) K260188 · LimFlow, Inc.

Substantially Equivalent

510(k) numberK260188

Submission

Device name
LimFlow Vector
Applicant
LimFlow, Inc.
Irvine, CA, US
Received
January 22, 2026
Decision date
March 18, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MGZ – Valvulotome
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4885
Specialty
Cardiovascular

Other 510(k)s with product code MGZ

510(k)DeviceApplicantDecision
K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)MGZ · Traditional Aveera Medical, Inc.07/03/2025SE
K221902LimFlow VectorMGZ · Traditional LimFlow, Inc.12/21/2022SE
K190267EZE SIT ValvulotomeMGZ · Traditional Lemaitre Vascular10/30/2019SE
K142660Antegrade LeMills ValvulotomeMGZ · Special LeMaitre Vascular, Inc.10/17/2014SE
K1400421.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional LeMaitre Vascular, Inc.04/10/2014SE
K132047Lemills ValvulotomeMGZ · Traditional LeMaitre Vascular, Inc.11/05/2013SE
K132190Expandable Lemaitre Valvulotome, Over-The-Wire Lemaitre ValvulotomeMGZ · Traditional LeMaitre Vascular, Inc.08/05/2013SE
K111884Over-The-Wire Expandable Lemaitre ValvulotomeMGZ · Special LeMaitre Vascular, Inc.07/29/2011SE
K080178Valvulotome by KovenMGZ · Traditional Koven Technology, Inc.07/28/2008SE
K022823Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520MGZ · Traditional Geister Medizin Technik GmbH07/01/2004SE

More from Geister Medizin Technik GmbH

510(k)DeviceDecision
K251376LimFlow ARCPDU · Special 05/31/2025SE
K242776LimFlow V-CeiverMMX · Special 02/14/2025SE
K221902LimFlow VectorMGZ · Traditional 12/21/2022SE
K221541LimFlow ARCPDU · Traditional 08/31/2022SE
K222083LimFlow V-CeiverMMX · Traditional 08/09/2022SE

Questions and answers

When was LimFlow Vector cleared by the FDA?

LimFlow Vector (K260188) received a 510(k) decision of Substantially Equivalent on March 18, 2026, 55 days after the submission was received.

What is the product code of K260188?

The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.