510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993341Substantially Equivalent

Intellisystem II Color Monitor

Merit Medical Systems, Inc., South Jordan UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K993341 is the FDA 510(k) clearance record for INTELLISYSTEM II COLOR MONITOR, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show 4 recalls naming K993341.

Clearance record

Decision date
Received
(20 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Merit Medical Systems, Inc. 1600 W. Merit Pkwy., South Jordan UT
510(k) summary
Summary
Third party review
No

Clearances, product code MAV

Trailing 12 months
1 clearance under product code MAV in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MAV, 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 20261
October 20260