Data / Medical devices / United States / LimFlow Inc.

LimFlow Inc.: FDA-registered device maker in Irvine, CA, United States, 6 510(k) clearances and 1 PMA approval

Name: LimFlow Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

LimFlow Inc. is registered with the FDA (registration 3023527320) in Irvine, CA, United States. It lists 4 device types. The FDA files 6 510(k) clearances and 1 PMA approval under its listings, the newest dated March 18, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3023527320
Address: 6001 Oak Canyon Suite 100, Irvine, CA, United States, 92618
Owner or operator: STRYKER CORP. (1811755)
Roles: Specification developer
First device listed: March 17, 2025
Registered through: 2026
Brand names listed: LimFlow ARC, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft, LimFlow System, LimFlow V-Ceiver, LimFlow Vector

Devices it lists

Device	Product code	Class	Role	Source
Catheter For Crossing Total Occlusions	PDU	2	Specification developer	accessdata.fda.gov
Device, Percutaneous Retrieval	MMX	2	Specification developer	accessdata.fda.gov
Stent Graft, Infrapopliteal, Venous Arterialization	QWN	3	Specification developer	accessdata.fda.gov
Valvulotome	MGZ	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 18, 2026	K260188	LimFlow Vector	MGZ	Substantially Equivalent	LimFlow, Inc.	accessdata.fda.gov
May 31, 2025	K251376	LimFlow ARC	PDU	Substantially Equivalent	LimFlow, Inc.	accessdata.fda.gov
February 14, 2025	K242776	LimFlow V-Ceiver	MMX	Substantially Equivalent	LimFlow, Inc.	accessdata.fda.gov
December 21, 2022	K221902	LimFlow Vector	MGZ	Substantially Equivalent	LimFlow, Inc.	accessdata.fda.gov
August 31, 2022	K221541	LimFlow ARC	PDU	Substantially Equivalent	LimFlow, Inc.	accessdata.fda.gov
August 9, 2022	K222083	LimFlow V-Ceiver	MMX	Substantially Equivalent	LimFlow, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 11, 2023	P220025	LimFlow System	QWN	8	January 7, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 5, 2025	98218	Class II	Ongoing	Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23	Incorrect expiration date	accessdata.fda.gov

Compare with other makers

Updated March 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.