510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K913994Substantially Equivalent

Monarch(tm) Inflation Syringe

Merit Medical Systems, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913994 is the FDA 510(k) clearance record for MONARCH(TM) INFLATION SYRINGE, 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 no recalls naming K913994.

Clearance record

Decision date
Received
(151 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. 79 W. 4500 S., Suite 9, Salt Lake City UT
510(k) summary
Statement
Third party review
No

Clearances, product code MAV

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