Chrysalis Intelligence · Sponsors · LimFlow, Inc.

LimFlow, Inc.

San Jose, CA, US · 6 510(k) clearances · 9 PMAs · 1 recalls

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Total clearances
6
2022-08-09 → 2026-03-18
Last 12 months
1
Product codes
3
Most recent
2026-03-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MGZ Valvulotome Class II Cardiovascular 2 2026-03-18
PDU Catheter For Crossing Total Occlusions Class II Cardiovascular 2 2025-05-31
MMX Device, Percutaneous Retrieval Class II Cardiovascular 2 2025-02-14
Class III

PMA approvals (9)

Total PMA records
9
Originals + supplements
Distinct product codes
1
First decision
2023-09-11
Most recent
2026-01-07
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-01-07 P220025-S008 LimFlow System 30-Day Notice QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown
2025-10-22 P220025-S007 LimFlow System Real-Time Process QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown
2025-07-09 P220025-S006 LimFlow System 30-Day Notice QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown
2025-02-12 P220025-S005 LimFlow System, LimFlow Crossing Stent Graft and LimFLow Extension Stent Graft Real-Time Process QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown
2024-12-20 P220025-S004 LimFlow System 135 Review Track For 30-Day Notice QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown
2024-07-11 P220025-S002 LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft Normal 180 Day Track QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown
2024-04-19 P220025-S003 LimFlow System 30-Day Notice QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown
2023-10-12 P220025-S001 LimFlow System Normal 180 Day Track No User Fee QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown
2023-09-11 P220025 LimFlow System Original QWN Stent Graft, Infrapopliteal, Venous Arterialization Unknown
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2025-12-05
DateSeverityStatusRecall # ProductCodeReason
2025-12-05 Class II Ongoing Z-1218-2026 Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23 — Incorrect expiration date
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-03-18 K260188 LimFlow Vector MGZ Class II Cardiovascular
2025-05-31 K251376 LimFlow ARC PDU Class II Cardiovascular
2025-02-14 K242776 LimFlow V-Ceiver MMX Class II Cardiovascular
2022-12-21 K221902 LimFlow Vector MGZ Class II Cardiovascular
2022-08-31 K221541 LimFlow ARC PDU Class II Cardiovascular
2022-08-09 K222083 LimFlow V-Ceiver MMX Class II Cardiovascular
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence