510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193507Substantially Equivalent

Merit ONE Snare System

Merit Medical Systems, Inc., Galway, IE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193507 is the FDA 510(k) clearance record for Merit ONE Snare System, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code MMX (Device, Percutaneous Retrieval). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K193507.

Clearance record

Decision date
Received
(30 days to decision)
Product code
MMX Device, Percutaneous Retrieval
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Merit Medical Systems, Inc. Parkmore Business Park W., Galway, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MMX

Trailing 12 months

FDA records hold no clearances under product code MMX in the trailing twelve months.

FDA records show no clearances under product code MMX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MMX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260