LimFlow ARC

FDA 510(k) K221541 · LimFlow, Inc.

Substantially Equivalent

510(k) numberK221541

Submission

Device name
LimFlow ARC
Applicant
LimFlow, Inc.
San Jose, CA, US
Received
May 27, 2022
Decision date
August 31, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PDU – Catheter For Crossing Total Occlusions
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

Other 510(k)s with product code PDU

510(k)DeviceApplicantDecision
K262013Kiba CTO Crossing CatheterPDU · Special Reflow Medical, Inc.08/28/2026SE
K252315Santreva™-ATK Endovascular Revasculariztion CatheterPDU · Traditional AngioSafe, Inc.09/22/2025SE
K251158PowerWire® 14 Radiofrequency Guidewire KitPDU · Traditional Baylis Medical Technologies, Inc.09/11/2025SESK
K251376LimFlow ARCPDU · Special LimFlow, Inc.05/31/2025SE
K232562PowerWire Radiofrequency Guidewire KitPDU · Traditional Baylis Medical Technologies, Inc.02/28/2024SESK
K230159SoundBite® Crossing System XS PeripheralPDU · Traditional Soundbite Medical Solutions, Inc.08/28/2023SE
K230594Tigereye ST CTO-Crossing CatheterPDU · Traditional Avinger, Inc.04/25/2023SE
K221163Tunnel Crossing CatheterPDU · Traditional Tractus Vascular, LLC01/19/2023SE
K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)PDU · Traditional Ra Medical Systems,Inc06/29/2022SE
K211802GoBack Crossing CatheterPDU · Traditional Upstream Peripheral Technologies, Ltd.03/01/2022SE

More from Upstream Peripheral Technologies, Ltd.

510(k)DeviceDecision
K260188LimFlow VectorMGZ · Special 03/18/2026SE
K251376LimFlow ARCPDU · Special 05/31/2025SE
K242776LimFlow V-CeiverMMX · Special 02/14/2025SE
K221902LimFlow VectorMGZ · Traditional 12/21/2022SE
K222083LimFlow V-CeiverMMX · Traditional 08/09/2022SE

Questions and answers

When was LimFlow ARC cleared by the FDA?

LimFlow ARC (K221541) received a 510(k) decision of Substantially Equivalent on August 31, 2022, 96 days after the submission was received.

What is the product code of K221541?

The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.