510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221902Substantially Equivalent

LimFlow Vector

LimFlow Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221902 is the FDA 510(k) clearance record for LimFlow Vector, a class II device, cleared for LimFlow, Inc. on under FDA product code MGZ (Valvulotome). FDA records list 6 510(k) clearances for LimFlow, Inc., from to . As of , FDA records show one recall naming K221902.

Clearance record

Decision date
Received
(174 days to decision)
Product code
MGZ Valvulotome
Regulation
21 CFR 870.4885
Device class
Class II
Review panel
Cardiovascular
Applicant
LimFlow, Inc. 3031 Tisch Way - 110 Plz. W., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MGZ

Trailing 12 months
1 clearance under product code MGZ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MGZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260